Clinical Research Trials with Dr. John Paul Runyon as Sub-Investigator


CLINICAL RESEARCH TRIALS (PHARMACEUTICALS):  DR. JOHN PAUL RUNYON AS [SUB-INVESTIGATOR]

Sub-Investigator
Praise: Prospective randomized Amlodipine survival evaluation.

Sub-Investigator
Caprie: Clopidogrel vs. aspirin in patients at risk of ischemic events.

Sub-Investigator
Dilacor XR in angina.

Sub-Investigator
Fantofarone (SR 33557 in patients with chronic stable angina pectoris.

Sub-Investigator
Adenosine as an adjunct to tissue-type Plasminogen Activator (rt-PA) in the treatment of acute myocardial infarction.

Sub-Investigator
Atlas: Assessment of treatment with Lisinopril and survival.

Sub-Investigator
Open-label safety study of intravenous Amiodarone HCL in patients with life-threatening ventricular tachycardia/fibrillation.

Sub-Investigator
Safety and efficacy of Cardizem CD for the treatment of stable angina pectoris.

Sub-Investigator
Efficacy and safety evaluation of Verapamil-GITS 240 mg in the treatment of stable angina pectoris.

Sub-Investigator
CARS: Coumadin/Aspiration Reinfarction Study.

Sub-Investigator
Impact: A randomized, double-blind, comparative safety and efficacy evaluation of Integrilin in patients receiving thrombolytic therapy for acute myocardial infarction.

Sub-Investigator
SWORD (Survival with Oral d-Sotalol): The effect of oral d-Sotalol on mortality in patients with atherosclerotic coronary heart disease and left ventricular dysfunction.

Sub-Investigator
Open-label dose range study of multiple oral doses of NE-10064 to determine safety and anti-arrhythmic efficacy in patients with inductible monomorphic ventricular tachycardia by Programmed Electrical Stimulation (PES).

Sub-Investigator
Open-label, long-term safety of Ro 40-5967 in the treatment of chronic stable angina.

Sub-Investigator
AFIB: Atrial Fibrillation investigation with Bidisomide.

Sub-Investigator
A randomized study of MK-383 in high-risk patients undergoing PTCA.

Sub-Investigator
Gusto II: Global use of strategies to open occluded arteries in acute coronary syndromes.

Sub-Investigator
IMPACT II: Two dosing regimens of Integrilin versus placebo for reducing the complications of coronary angioplasty

Sub-Investigator
Comparison of Oral BMS 180291, Atenolol and placebo in subjects with coronary artery disease experiencing episodes of ambulatory myocardial ischemia.

Sub-Investigator
Comparison of the efficacy and safety of extended outpatient treatment with subcutaneous Normiflo versus placebo for the prevention of venous thromboembolism in patients after hip or knee replacement surgery.

Sub-Investigator
CORE: Collaborative Organization for RheothRx Evaluation.

Sub-Investigator
Antihypertensive activity and safety of 100, 200, and 300 mg SR 47436 (BMS-186295) in mild-to- moderate hypertension.

Sub-Investigator
Double-blind and open-label study of orally administered Dofetilide in patients with an implanted arrhythmia control device.

Sub-Investigator
Evaluation of orally administered Dofetilide in patients with symptomatic Paroxysmal Atrial Fibrillation/Flutter (pAF, pAFL) or Paroxysmal Supraventricular Tachycardia (pSVT).

Sub-Investigator
Effects of BMS 180,291 or placebo on indices of myocardial ischemia in patients with chronic stable angina pectoris undergoing exercise.

Sub-Investigator
Comparison of Intravenous d-Sotalol and placebo in the conversion of atrial fibrillation or flutter to sinus rhythm.

Sub-Investigator
ALLHAT (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial).

Sub-Investigator
Trial of SR47436 (BMS-186295) for treatment of hypertension.

Sub-Investigator
MK-383 Alone and MK-383 in combination with heparin vs. heparin alone in patients with high risk unstable angina/non-Q-wave myocardial infarction.

Sub-Investigator
VEST Trial: Vesnarinone in heart failure.

Sub-Investigator
EPILOG: Clinical outcome following percutaneous coronary intervention in patients treated with 7e3 Fab Bolus plus 12-hour infusion given with either standard dose weight-adjusted or low-dose weight-adjusted heparin.

Sub-Investigator
MK-383 in patients undergoing PTCA (RESTORE).

Sub-Investigator
Double-blind trial of Azimilide for treatment of atrial fib/flutter and/or PSVT.

Sub-Investigator
Open-label trial to assess long-term safety of Azimilide.

Sub-Investigator
TIMI 10 pilot (TNK-tPA in Acute MI).

Principal Investigator
Telmisartan in mild-to-moderate hypertension.

Sub-Investigator
Xemilofiban Hydrochloride post-stent placement.

Sub-Investigator
PPR Verapamil vs. Procardia XL in treatment of hypertension.

Sub-Investigator
PPR Verapamil vs. Norvasc and Atenolol in patients with chronic stable angina.

Sub-Investigator
RAPPORT: ReoPro in acute myocardial infarction.

Sub-Investigator
Comparison of Mibefradil/Amlodipine in treatment of chronic stable angina.

Sub-Investigator
GUSTO III: Reteplase (r-PA) versus Accelerated Alteplase (t-PA) for treatment of AMI.

Sub-Investigator
Open-label administration of Telmisartan as monotherapy or in combination with other antihypertensive medications.

Sub-Investigator
BMS-200980 in subjects with AMI. (INTIME).

Sub-Investigator
BEST: Beta Blocker Evaluation of Survival Trial.

Sub-Investigator
Trial Comparing Lotrel/Amlodipine for HTN.

Sub-Investigator
Trial Comparing Lotrel/Nifedipine for HTN.

Sub-Investigator
Novastan in patients with heparin-induced thrombocytopenia undergoing PTCA, atherectomy or stent implantation.

Sub-Investigator
PEACE Trial: Prevention of Events with Angiotensin Converting Enzymes Inhibitor Therapy.

Sub-Investigator
Losartan in patients with non-insulin dependent diabetes.

Sub-Investigator
Irbesartan in hypertensive patients with type ii diabetic nephropathy.

Sub-Investigator
Pilot Study: Dosing Regimens of Integrilin vs. Placebo in Patients Undergoing Percutaneous Coronary Intervention.

Sub-Investigator
Dose ranging study of BMS-186716 in mild to mod. Htn (DMPI – NEPACE).

Sub-Investigator
SPICE: Study of Patients Intolerant Of Converting Enzyme Inhibitors.

Sub-Investigator
BR1 vs. Albunex as a contrast enhancing agent for transthoracic echo at rest.

Principal Investigator
CILOSTAZOL VS. PENTOXIFYLLINE or placebo in patients with intermittent claudication secondary to Peripheral Vascular Disease (PVD study).

Sub-Investigator
Controlled Onset Verapamil Investigation of Cardiovascular Endpoints (CONVINCE TRIAL).

Sub-Investigator
Open-label study of Novastan in patients with Heparin-Induced Thrombocytopenia (HIT)/Heparin- Induced Thrombocytopenia and Thrombosis Syndrome (HITTS).

Sub-Investigator
Open-label, long-term study of the antihypertensive activity and safety of BMS-186716, a dual metalloprotease inhibitor, in the treatment of hypertension.

Sub-Investigator
Multi-country, randomized, double-blind, parallel, placebo-controlled trial to assess the effect of Valsartan on morbidity and mortality, signs and symptoms and quality of life in patients with stable chronic congestive heart failure (NYHA Class II-IV).

Sub-Investigator
REOPRO readministration registry – a phase IV observational study.

Sub-Investigator
Genetic Analysis Of Complex Human Traits: Application To Premature Atherosclerotic Heart Disease (GENE QUEST).

Sub-Investigator
A multicenter, double-blind study to assess the efficacy and safety of 50, 100 & 125 mg of Azimilide Dihydrochloride for prophylactic treatment of symptomatic atrial fibrillation / flutter and/or symptomatic paroxysmal superventricular tachycardia.

Sub-Investigator
A multicenter, open label clinical trial to assess the long-term safety of 100 mg of azimilide dihydrocholoride in patients with atrial fibrillation/flutter and/or paroxysmal supraventricular tachycardia.

Sub-Investigator
A phase 1, open-label… to assess the safety, tolerability, and pharmacokinetics of intracoronary administration of RhVEGF in subjects with viable but underperfused myocardium.

Sub-Investigator
Pilot evaluation of the effects of the DMP inhibitor BMS-186716 on functional capacity in subjects with heart failure.

Sub-Investigator
54-week open label assessment of safety & efficacy profile of Atorvastatin as compared to Simvastatin when used to optimally control pts with mixed dyslipidemia.

Principal Investigator
The GUARDIAN trial – Guard during ischemia against necrosis. A double-blind, placebo-controlled, multinational trial to investigate the effect of the Na/H exchange inhibitor HOE 642 (cariporide) on all- cause mortality and myocardial infarction in pts at risk of myocardial necrosis.

Sub-Investigator
Evaluation of safety/tolerability of long-term treatment with DMP-inhibitor BMS-186716 or Lisinopril in subjects with heart failure.

Sub-Investigator
A Phase 3, open label titration study of the chronic efficacy of OPC-18790 for treatment of patients with heart failure.

Sub-Investigator
Randomized, double-blind…AMP 579 in patients with acute myocardial infarction treated with primary angioplasty.

Sub-Investigator
12-week, DB …effect on platelet aggreg. of a dose range of SB 214857 when added to aspirin in patients with MI… APLAUD.

Sub-Investigator
Orbofiban (SC 57099B) (10 & 20 mg twice daily) in pts with stabilized ischemic syndromes.

Sub-Investigator
A Phase 1, open-label, multicenter, dose escalation study to assess safety, tolerability and pharmacokinetics of multiple intravenous administration of rhVEGF in adults with viable but underperfused myocardium.

Sub-Investigator
Double-blind, randomized, multicenter trial of single bolus lanoteplase vs. accelerated alteplase for treatment of subject with AMI (in TIME II).

Co-Investigator
SPEED: Open-label angiographic trial evaluating the benefit of ReoPro plus 12-hr. infusion with and without thrombolytic therapy for AMI.

Sub-Investigator
EXCITE: Xemilofiban administration to patients undergoing coronary angioplasty or stent placement.

Sub-Investigator
ALIVE (Azimilide Post Infarct Survival Evaluation Trial): Determine the effect of 75 or 100 mg of orally administered azimilide vs. placebo on survival in recent MI patients at risk of sudden death.

Sub-Investigator
OPUS (TIMI 16): Trial evaluating the efficacy and safety of Orbofiban in patients with unstable coronary syndromes.

Sub-Investigator
COPERNICUS: Carvedilol prospective randomized cumulative survival trial (The effect of Carvedilol on mortality in patients with severe CHF).

Sub-Investigator
RECREATE Trial: Rescue of closed arteries treated by stent for threatened or abrupt closure.

Sub-Investigator
ORATOR: Oral glycoprotein IIb/IIIa antagonist (RPR 109891) vs. ticlopidine on coronary stent revascularization.

Sub-Investigator
P-selectin feasibility study.

Sub-Investigator
Rapid platelet function analyzer to assess platelet function during coronary interventions.

Sub-Investigator
Management of acute coronary syndrome with p-selectin profile (MAPS1).

Sub-Investigator
TIMI 15B. Trial to assess safety and efficacy of IV Klerval administration 24 to 96 hrs, followed by oral Klerval administration for 4 weeks in pts with acute coronary syndromes.

Sub-Investigator
Study to assess the equivalence of the accumetrics Rapid Platelet Function Assay (RPFA) in pts who are undergoing coronary intervention procedures to platelet aggregometry using a Chrono-Log aggregometer for detection of platelet aggregation.

Sub-Investigator
Phase II, randomized, double-blind, multi-center, acetylsalicylic acid-controlled, multidose study of DMP 754 in pts with coronary artery disease.

Sub-Investigator
RPFA II: Using a Chrono-Log aggregometer for detection of platelet aggregation.

Principal Investigator
Study of time course, magnitude and consistency of platelet inhibition by Abciximab, Aggrastat or Eptifibatide in patients with unstable angina pectoris undergoing PTCA.

Sub-Investigator
ASTRA Trial: Platelet Aggregation Response of IV AR-C69931MX in patients undergoing PTCA, with or without stent.

Sub-Investigator
NICE-4 Trial: Safety of Enoxaparin therapy in patients undergoing PTCA receiving concomitant Abciximab therapy.

Sub-Investigator
REVIVE Trial: DUET Stent for saphenous vein grafts.

Sub-Investigator
Study evaluating platelet function with Accumetrics Ultegra-Rapid Platelet Function Assay (RPFA) in patients undergoing coronary interventions using Platelet Glycoprotein IIb/IIIa inhibitors (RPFA-4 study).

Sub-Investigator
SAFER Study: Saphenous Vein Graft Angioplasty Free of Emboli Randomized Study.

Sub-Investigator
DMP 754 (Roxifiban) in combination with aspirin in patient with CAD.

Sub-Investigator
VALIANT Trial: Valsartan in AMI.

Sub-Investigator
BRAVO: Blockade of the GP IIb/IIIa receptor to avoid vascular occlusion (Lotrafiban or placebo).

Sub-Investigator
PRESTO: Prevention of restenosis with Tranilast in its outcomes.

Sub-Investigator
ENABLE-2: Endothelin Antagonist Bosentan in lowering cardiac events in heart failure

Sub-Investigator
Recombinant Fibroblast Growth Factor: 2 (rFGF-2) in patients with CAD.

Sub-Investigator
Dalteparin/Abciximab in combination during PCI for acute coronary syndrome (Fragmin). ]

Sub-Investigator
OVERTURE: Omapatrilat vs. Enalapril randomized trial of utility of reducing events.

Sub-Investigator
Ultegra reference range study.

Sub-Investigator
Extension trial to evaluate one-year safety in pts. with CAD who have been treated with intracoronary rFGF-2 or placebo in Chiron Protocol CS-FGF002.

Sub-Investigator
Evaluate the effects of twice daily Celecoxib vs. placebo on blood pressure in HTN patients whose blood pressure is controlled with the ACE inhibitor, Lisinopril.

Sub-Investigator
Health Alliance Protocol for pharmacologic reperfusion of AMI: evaluation of the benefit of ReoPro bolus plus 12-hour infusion with reduced dose thrombolytic therapy for AMI.

Sub-Investigator
A blinded, randomized comparative trial of Dalteparin vs. unfractionated heparin in conjunction with Abciximab Platelet GP IIb/IIIa inhibition during and following elective PCI.

Sub-Investigator
A study to evaluate blood samples obtained from pts. for development of platelet function assay (Accumetrics).

Sub-Investigator
Ultegra Reference Range Protocol: (Accumetrics).

Sub-Investigator
DISTINCT abrupt closure or threatened abrupt closure registry.

Sub-Investigator
THRIVE V: Double-blind, efficacy & safety study of the oral direct thrombin inhibit, H 376/96 vs. standard therapy in pts. with acute DVT with or without PE.

Sub-Investigator
A double-blind … study to compare the safety & efficacy of Diltiazem HCL extended release capsules to placebo dose at bedtime & to G99 dosed in the AM in pts. with essential HTN.

Sub-Investigator
PROVE IT: Pravastatin or Atorvastatin evaluation and infection therapy.

Sub-Investigator
A long-term, O/L Study of CS-866 & Hydrochlorothiazide in patients with Essential HTN.

Sub-Investigator
OCTAVE: Omapatrilat cardiovascular treatment assessment vs. Enalapril .

Sub-Investigator
PYRAMID: A parallel-dose randomized,…. …study of YM337 in Pts. undergoing PCI to provide pharmacokinetic, pharmacodynamic & safety data.

Sub-Investigator
REPLACE: Randomized evaluation in PCI linking Angiomax to reduced clinical events.

Sub-Investigator
Field trial evaluation of the Rapidpoint coag & low molecular weight heparin card.

Sub-Investigator
SAGE: Study assessing goals in the elderly. …study comparing the effects of aggressive lipid lowering with moderate lipid lowering on the reduction of the total duration of myocardial ischemia ….measured by Holter monitoring by comparing the maximal doses of two statins.

Sub-Investigator
Double-blind, randomized, ……..study of Ranolazine SR 750 mg twice a day administered alone & in combination with Digoxin 0.125 mg once a day in pts. with CHF.

Sub-Investigator
AVALON: evaluation of the safety & efficacy of dual therapy with Atorvastatin plus Amlodipine when compared to either therapy alone in the tx. of pts. with simultaneous hyperlipidemia:

Sub-Investigator
Beraprost in patients with intermittent claudication: a continuation study.

Sub-Investigator
8 week randomized double-blind….evaluate the effects of ZD4522 40 mg on myocardial ischemia in subjects with CAD (protocol 4522IL/0043).

Sub-Investigator
TELLAR: 6-week, dose-comparison study ….efficacy of Rosuvastatin vs. Atorvastatin, Cerivastatin, Pravastatin & Simvastatin in subjects with hypercholesterolemia (protocol 4522IL/0065).

Sub-Investigator
Effect of Oral NO-1886 on lipoproteins in subjects with Type II Diabetes Group Mellitus who are receiving statin therapy (TAP NO-18886-01-017).

Principal Investigator
EXPEDITION Trial: …IV Treatment …HOE642 on all-cause mortality & non-fatal MI in Pts. at risk of myocardial necrosis during and after CABG surgery.

Sub-Investigator
AQUAVIT: Aquaretic Vasopressin V2 Receptor InhibitorTrial.

Sub-Investigator
SYNERGY: A prospective, randomized, open-label multicenter study in pts. presenting with Acute Coronary Syndromes (ACS).

Sub-Investigator
PRE-CHILL Study: cryoplasty hyperplasia inhibition prevents late loss feasibility.

Sub-Investigator
Accumetrics (P95053): Evaluation of baseline (uninhibited ) reference range for the Ultegra System in subj. receiving tx. for CAD.

Sub-Investigator
A randomized, ….study to compare the blood pressure response of pts. with group moderate HTN receiving Lercanidipine or placebo.

Sub-Investigator
Study of the effects of Zoniporide on perioperative cardiac events in high risk subjects undergoing noncardiac vascular surgery.

Sub-Investigator
CREST: Cilostazol for Restenosis Trial.

Sub-Investigator
PREVAIL: Study to evaluate the safety & efficacy of BO-653 in the prevention of post-angioplasty restenosis in stented lesions.

Sub-Investigator
REPLACE-2: A randomized evaluation in PCI lining Angiomax to reduced clinical events.

Sub-Investigator
A Phase IIIb, multicenter…..the safety, efficacy & tolerability of Fenoldopam Mesylate in subjects undergoing invasive cardiology procedures:

Sub-Investigator
REVIVE: Randomized evaluation of IV Levosimendan efficacy vs. placebo in the short term tx. of decompensated chronic heart failure.

Sub-Investigator
TRANSCEND: Telmisartan randomized assessment study in ACE-inhibitor intolerant subjects with cardiovascular disease.

Sub-Investigator
ELECT study: Evaluating Enox Clotting Times. Multicenter evaluation of the Rapidpoint ENOX monitoring system among PCI patients receiving enoxaparin.

Sub-Investigator
A randomized, double-blind, multicenter, positive controlled, parallel-group study to evaluate the
& efficacy of Amlodipine and Benazepril administered in combination compared to Benazepril alone in hypertensive patients not adequately controlled with Benazepril alone.

Sub-Investigator
SOLACE: A multicenter, randomized, double-blind, parallel group study comparing the efficacy of Lotrel versus Amlodipine in the treatment of moderate to severe hypertension– Principal Investigator

Sub-Investigator
A randomized, double-blind, multicenter, multifactorial, placebo-controlled, parallel group study to evaluate the efficacy and safety of Valsartan and amlodipine combined and alone in hypertensive patients.

Sub-Investigator
A Phase II, randomized….pilot study of ETC-588 in patients with acute coronary syndromes.

Sub-Investigator
Evaluation of the thrombolytic assessment (TAS) & thrombin inhibitor management (TIM-2) testcard.

Sub-Investigator
ACT (guided Dalteparin in percutaneous coronary intervention (ACT: ONE).

Sub-Investigator
SWITCH: Switching from Lovenox (enoxaparin) to Angiomax in pts. with acute coronary syndromes without ST-segment elevation undergoing PCI.

Sub-Investigator
TIMI-38, A Comparison of CS-747 and Clopidogrel in acute coronary syndrome subjects who are to undergo percutaneous coronary intervention.

Sub-Investigator

TENACITY: A randomized, multicenter, double-blind, Abciximab-controlled study to evaluate the efficacy of Tirofiban versus Abciximab among subjects undergoing percutaneous coronary intervention with stent placement receiving Bivalirudin or Heparin.

Sub-Investigator
Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) An imaging study in patients with unstable atherosclerotic lesions.

Sub-Investigator
IMPROVE IT: IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT).

Sub-Investigator
SWAP: SWitching Anti-Platelet Study: A pharmacodynamic comparison of Prasugrel (LY640315) versus Clopidogrel in subjects with acute coronary syndrome who have recently undergone percutaneous coronary intervention and are receiving Clopidogrel.

Sub-Investigator
CHAMPION: A clinical trial comparing Cangrelor to Clopidogrel in subjects who require PCI.

Sub-Investigator
Collection of carotid plaque for methods adaptation and optimization.

Sub-Investigator
INNOVATE-PCI: A randomized, double-blind, active-controlled trial to evaluate intravenous and oral PRT060128, a selective and reversible P2Y12-Receptor Inhibitor, vs. Clopidogrel, as a novel antiplatelet therapy in patients undergoing non-urgent percutaneous coronary interventions.

Sub-Investigator
Protocol:A01-03:Double-Blind,randomized,placebo-controlled,12-weekstudy ofthe safety and efficacy of ATHX-105 Phosphate for the treatment of obesity.

Sub-Investigator
A randomized, double-blind, outpatient, crossover study of the anti-platelet effects of AZD6140 compared with Clopidogrel in patients with stable coronary artery disease previously identified as Clopidogrel Non- responders or Responders (RESPOND).

Sub-Investigator
A randomized, double-blind, outpatient, crossover study of the anti-platelet Effects of AZD6140 compared with Clopidogrel in patients with stable coronary artery disease previously identified as Clopidogrel Non- responders or Responders (RESPOND).

Principal Investigator
Injection of Autologous CD34-positive cells for improved symptomatic relief and ischemic wound healing in subjects with moderate or high-risk critical limb ischemia.

Sub-Investigator
A Phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of PROCHYMAL® (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion following acute myocardial infarction.

Sub-Investigator
INFUSE-AMI: A 2×2 factorial, randomized, multicenter, single-blind evaluation of intracoronary Abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior st-segment elevation myocardial infarction.

Sub-Investigator
DAPT: A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of Dual Antiplatelet Therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions..

Sub-Investigator
SOLID / TIMI-52: A clinical outcomes study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

Sub-Investigator
Cardiovascular outcomes study to evaluate the potential of Aleglitazar to reduce cardiovascular risk in pts with a recent ACS event and type 2 diabetes mellitus (Alecardio).

Sub-Investigator
RIVAROX-ACS-3001/ATLAS II TIMI 51: A randomized, double-blind, placebo-controlled, event- driven multicenter study to evaluate the efficacy and safety of Rivaroxaban in subjects with acute coronary syndrome.

Sub-Investigator
ELEVATE / TIMI 56: Escalating cLopidogrEl by inVolving A geneTic stratEgy –Thrombolysis In Myocardial Infarction 56.

Sub-Investigator
A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous Canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP (#CACZ885M2301).

Sub-Investigator
BOSS: Evaluation of Sodium Bicarbonate to Reduce Contrast-Induced Chronic Kidney Injury in Subjects with Advanced Chronic Kidney Disease (CKD) Who are Undergoing Angiography.