Principal Investigator And Clinical Cardiovasular Research Trials
Factors Influencing the Development and Progression of Cardiovascular Disease in Men and Women Throughout Their Life Span – investigator initiated study
Calcium score as a predictor of CVD risk as compared with RRS: could it be additive?- investigator initiated study
Choice II: EFC13786: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Primary Hypercholesterolemia not treated with a statin (December 2013- Present)
Exscel Study: BCB109:A Randomized, placebo controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus (December 2013 – Present)
ODYSSEY OPTION I: R727-CL-1110:A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin (May 2013 – Present)
ODYSSEY OPTION II: R727-CL-1118: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin (May 2013 – Present)
ODYSSEY COMBO II: EFC11569: A Randomized, Double Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 versus Ezetimibe in High Cardiovascular Risk Patients with Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy (April 2013 – Present)
ODYSSEY OUTCOMES: EFC11570: A Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Effect of SAR236553/REN727 on the Occurrence of Cardiovascular Experienced Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome (Mar 2013- Present)
ODYSSEY/STATIN INTOLERANCE: R727-CL-1119: Double-blind, Double Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins (Jan 2013 – Present)
TASLY PHARMACEUTICALS: T89-07-CAESA: A Phase III, Double Blind, Placebo-Controlled, Randomized, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of T89 in Patients with Chronic Stable Angina Pectoris (Jan 2013- Present)
AMGEN/FOURIER:20110118: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG145 is Used in Combination With Statin Therapy in Patients with Clinically Evident Cardiovascular Disease (Dec. 2012- Present)
F. Hoffmann-La Roche Ltd: BC280287 A Phase 3B Study To Evaluate The Potential Of Aleglitazar To Reduce Cardiovascular Risk In Patients With Stable Cardiovascular Disease And Glucose Abnormalities (Nov 2012- July 2013)
ODYSSEY: LTS11717:Long-term safety and tolerability of REGN727/SAR236553 in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their lipid modifying therapy: a randomized, double-blind, placebo-controlled study ( July 2012-present)
GLORIA-AF:Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients with Atrial Fibrillation (phase II/III) (May 2012-Present)
ISHEMIA: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (May 2012-Present)
LTOLE: Averroes Long Term Open Label Extension Study
AVERROES: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double blind trial; protocol CV185048
DUT-MD-304: A phase III, randomized, Double-blind, placebo controlled, multicenter study to evaluate the safety and efficacy of Dutogliptin in patients with type 2 Diabetes Mellitus on background treatment with Pioglitazone
DUT-MD-303: A phase III, randomized, Double-blind, placebo controlled, multicenter study to evaluate the safety and efficacy of Dutogliptin in patients with type 2 Diabetes Mellitus on background treatment with Glimepiride with or without Metformin
CFD 109701: The incidence of orthostatic hypotension with the co-administration of CR formulation of Carvedilol in a fixed dose combination product with Lisinopril.
CV185048: Apixaban versus Acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment, a randomized, double blind trial.
DAIICHI-SANKYO: A prospective, open label, single arm study to evaluate the safety and efficacy of an Olmesartan medoxomil based treatment regimen in elderly patients with hypertension.
FOREST: A prospective, randomized, open label, parallel group study to compare the tolerability of Nabivolol to other beta blockers in patients with stage I or II hypertension.
TAKEDA: A phase 3 randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of TAK-491 in subjects with essential hypertension.
DAR 312: A phase 3 randomized, double blind, placebo, and active controlled, multi-center study to evaluate the safety and efficacy of Darusentan in subjects with resistant hypertension receiving combination therapy with three or more antihypertensive drugs including a diuretic as compared to Guanfacine or placebo.
DAR 312-E: A double blind, active controlled, long term safety extension study of optimized doses of Darusentan in subjects with resistant hypertension despite receiving combination therapy of three or more antihypertensive drugs including a diuretic as compared to Guanfacine.
ABBOTT- Protocol #MO5-748 A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia(February 2006-2008)
AGELESS: Novartis Pharmaceuticals trial entitled: “A 36 week randomized, double-blind, parallel-group, multicenter, active-controlled, optional titration study comparing an aliskiren-based regimen to a lisinopril- based regimen in patients > 65 years old with systolic essential hypertension” Protocol Number: CSPP100A23449 (Jan.2006-2008)
ATHENA- Protocol #EFC 5555 - A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (AF/AFL)IND # 49,484(July 2005-2009)
COREG (CFD105453): A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (Zestril) or a Combination of One of the Doses of Each Medication(Aug.2006- 2008)
DAR 311-DORADO- Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or More Antihypertensive Drugs, Including a Diuretic (May 2006- 2009)
DAR-311-E - DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension: A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or More Antihypertensive Drugs, Including a Diuretic(Sept. 2006- Present)
FOCUS- Protocol AGI-1067-051: Follow up Of Clinical Outcomes: The Long-term AGI-1067 plus Usual Care Study(Aug. 2006-2008
PROTECT: A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy. Protocol Number: CKI-301 (July 2006-June 2007)
PROVIDENCE-1 -Prospective, Randomized, Double-Blind (Phase 3) Study of Rifalazil Treatment On the Number of Vascular Interventions and Peripheral Vascular Disease Endpoints in Chlamydia Pneumoniae Seropositive Patients Protocol #ABI-1648-022
RedHF: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia Protocol Number: 20050222(March 2006-Present)
RELY - Randomized Evaluation of Long term anticoagulant therapy comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY)(November 2005-2007)
TREAT- Protocol # 20010184,IND Number: BB IND-11621, Trial to Reduce Cardiovascular Events with Aranesp® Therapy(Sept.2004- 2009)
APEX- Protocol # 2003056 A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients with Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. (June 2004-May 2006)
ARISE - Protocol #AGI-1067-042 Aggressive Reduction of Inflammation Stops Events (June 2003- August 2006)
AMADEUS- Protocol A multicenter, randomized, open-label, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous idraparinux (SanOrg 34006) with adjusted-dose oral vitamin-K antagonists in the prevention of thromboembolic events in patients with atrial fibrillation.(Sept.2003-March 2006)
BMC Hypertension study- The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension (CV131176)(November 2005- March 2006)
COREG( 105517)/ 103560 - A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG™ MR) and Metoprolol Succinate Extended Release (Toprol-XL®) on the Reduction of Microalbuminuria in Patients with Hypertension and Microalbuminuria.( May 2005- 2007)
EVEREST Protocol # 156-03-236 Multicenter, Randomized, Double-blind, Placebo-controlled study to evaluate the long term efficacy and safety of oral Tolvaptan tablets in subjects hospitalized with worsening congestive heart failure.(Aug.2003 – 2005)
NOVACARDIA STUDY- A randomized, double-blind, placebo controlled, dose escalation study of the effects of KW-3902 on diuresis in patients with congestive heart failure (CHF) refractory to high dose diuretic therapy(July 2005-Jan. 2006)
Novartis Pharmaceuticals Trial: A 6-week, multicenter, randomized, double-blind, parallel-group study to evaluate the combination of valsartan/HCTZ (160/12.5mg with forced titration to a maximum dose of 320/25mg) compared to valsartan monotherapy ( 160mg with forced titration to 320mg) as initial therapy in patients with severe hypertension. Protocol Number: CVAH631D2301(Nov.2005-2006)
ONO-5129POU006 –Randomized double-blind, placebo-controlled pharmacodynamic evaluation of Ono-5129 in patients with treatment naïve type II Diabetes mellitus(May 2005-December 2006)
TRIUMPH- Protocol :A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Nitric Oxide Synthase Inhibition with Tilarginine Acetate Injection in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction, or "The TRIUMPH Study: Tilarginine Acetate Injection in a Randomized International Study in Unstable AMI Patients/Cardiogenic Shock"(June 2005- 2006)
TROPIC- Protocol MA-03010401The dose response of Niacin ER/Lovastatin on peak walking time in patients with intermittent Claudication – a Matrix design ( July 2003 –2005
A-Heft (African American Heart Failure Trial)- Protocol A placebo-controlled trial of BiDil Added to standard therapy in African American patients with heart failure. (2003-July 2004)
AVALIDE – Protocol #L8829 (CV131-170) The efficacy and safety of Avalide 150/12.5 mg, and Avalide 300/25 mg in patients with hypertention uncontrolled on monotherapy.(June 2003- July 2004)
AVANDIA 347- ProtocolBRL 49653C/347 A Multicenter, Randomized, Double-Blind, Parallel- Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 weeks in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled on Insulin(March 2003-March 2004)
DAR 201- Protocol# A Phase II Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic(July 2004- 2006)
ICPOP - The Effect of Niacin ER/Lovastatin on Peak Walking Time in Patients with Intermittent Claudication (May 2004 – 2006)
NAVIGATOR Protocol # CDJN608B2302 Novartis Pharmaceuticals trial entitled: A multinational, randomized, double-blind, placebo-controlled, forced-titration, 2 x 2 factorial design study of the efficacy and safety of long term administration of nateglinide and valsartan in the prevention of diabetes and cardiovascular outcomes in subjects with impaired glucose tolerance (IGT)( July 2003- 2008)
TAK 536 - A Phase II, Double-Blind, Randomized, Placebo-Controlled, Dose- ranging Study of the Efficacy, Safety, and Tolerability of TAK-536 in Patients with Mild to Moderate Uncomplicated Essential Hypertension -01-03-TL-536-002( Aug.2004-2006)
TAK 525 - A Phase II Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety and Tolerability of Pioglitazone HCl (ACTOSÒ) in combination with TAK-536 in Subjects with Type 2 Diabetes Protocol #: 01-04-TL-OPI-525(Aug 2004-June 2005)
TAKEDA MCC-135- Protocol No.: 01-02-TL-MCC135-001A Phase II, Double- Blind, Randomized Exploratory, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of MCC-135 Comparing QD Vs BID Doses in Subjects with Congestive Heart Failure, NYHA Class II/III (Sep 2002-2004)
SOLAR- Protocol-4522US/0003:ARandomized,Open-Label,3-ArmParallel-group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin with Atorvostatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High-.risk Subjects with Hypercholesterolemia in the Managed Care Setting(July 2002-2004).
EXCLAIM- Protocol XRPA4563C/3501: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely III Medical Patients with Prolonged Immobilization(2002- 2004).
NEB - 203 A Double-Blind, Randomized, Multi-Center , Five Treatment Study Of The Effects Of Nebivolol Compared To Atenolol On Cardiovascular Hemodynamics And Exercise Capacity In Patients With Mild To Moderate Hypertension- Protocol #NEB-203(March 2002- 2004).
COREG 105517/ 347: A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients with Type II Diabetes Mellitus-SB 105517/347(March 2002- 2004).
ADVANCE-CVAH631AUS01: “A Double Blind, Randomized, Parallel Group Study Comparing the Effects of Diovan HCTÒ 160/12.5mg to Amlodipine 10mg in African American Patients with Mild to Moderate Hypertension.(Dec 20012003).
Mitsubishi Protocol, A Phase II, Double-Blind, Randomized, Placebo Controlled, Dose Comparative Study of the Efficacy, Tolerability and Safety of MCC-135 in Subjects with Chronic Heart Failure, NYHA Class II/III(March 2001-2003).
CRISP, “A Single- Arm, Open Label Study Of Cerivastatin (Baycol) In Community- Based Patients With Hypercholesterolemia At Risk For Cardiovascular Disease And Patients With Cardiovascular Disease” (Dec. 2000-August 2000)
Protocol DTI-0009/003, Phase II, Multi-Center, Double-Blinded, Placebo-Controlled, Dose- Finding Efficacy and Safety Study of the A1-Adenosine Receptor Agonist DTI-0009 Administered Intravenously to Patients with Atrial Fibrillation (Dec. 2000-2001)
EPERELONE, A Double Blind, Randomized, Placebo-Controlled Trial Evaluating The Safety and Efficacy of Eplerenone in Patients with Heart Failure Following Acute Myocardial Infarction, IND #51,780 (Dec. 2000-May 2001).
SPORTIF V: Efficacy & Safety Study of the Oral Direct Thrombin Inhibitor H 376/95 Compared with Dose-Adjusted Warfarin (Coumadin) in the Prevention of Stroke & Systemic Embolic Events in Patients with Atrial Fibrillation Protocol #: 233 (SH-TPA-0005) (July 2000-2004).
TAKEDA 504: A Randomized, Double-Blind, Comparator-Controlled Study of Pioglitazone HCI vs. Glyburide in the Treatment of Subjects with Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild to Moderate CHF - Protocol #: 01-00-TL-OPI-504 (May 2000-2002).
TAKEDA 520: A Randomized, Double-Blind, Comparator-Controlled Study of Pioglitazone HCL vs Glyburide in the Treatment of Subjects with Type 2(Noninsulin Dependent)Diabetes Mellitus and Mild Cardiac Disease(NYHA I).
BRAVO, “Blockade of the GP IIB/IIIA Receptor to Avoid Vascular Occlusion” Protocol Number: SB 214857/030 (1999-2000).
ENABLE-2, "Endothelins Antagonist Bosentan for Lowering cardiac Events in heart failure”: Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effects of Ro 47-0203 (Bosentan) on the Morbidity and Mortality of Patients with Chronic Heart Failure (Bosentan), (March 1999-2002).
VALIANT, “VALsartan In Acute myocardial infarctions”: Multinational, Multicenter, Double-Blind, Randomized, Active Controlled, Parallel Group Study Comparing The Efficacy And Safety Of Long-Term Treatment With VALsartan, Captopril And Their Combination In High-Risk Patients After Myocardial Infarction, (February 1999-2002).
OPUS ORBOFIBAN STUDY 159-97-02-026: OPUS-T1MI 16: A Phase III, International Randomized, Double Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Orbofiban in Patients with Unstable Coronary Syndromes. IND No. 49, 380. (May 1998-1999).
AFFIRM TRIAL, “Atrial Fibrillation Follow-up Investigation of Rhythm Management”: Sponsored by National Heart, Lung, and Blood Institute, National Institutes of Health. (May 1998-2001)
Randomized, Open-Label, Active Controlled, Multicenter Phase III Safety study of Two Doses of NATRECOR hBNP Administered as a Continuous Infusion in Treatment of Decompensated CHF. (1997-Completed).
INVEST (International Verapamil-Trandolopril Study) is a Randomized, Controlled, Clinical Trial Comparing a Calcium Antagonist Treatment Strategy (Isoptin SR) with a Non-Calcium Antagonist Treatment Strategy for the Control of Hypertension in Primary Care Coronary Artery Disease Patient Population
A Randomized, Placebo-Controlled, Parallel-Group Study of C-866 with Long-Term Safety Evaluation In Patients with Essential Hypertension. (1997-Completed).
REACH I TRIAL, A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effects of Ro 470203 (Bosentan) on the Morbidity and Mortality of Patients with Chronic Heart Failure. (1997-1998 Completed).
REACH II TRIAL OPEN-LABEL, Long-Term study in Patients with Chronic Heart Failure who Participated in Controlled Clinical Studies with Bosentan. (1997-Completed).
MERIT, A Double-Blind, Placebo Controlled Survival Study with Toprol XL in Patients with Decreased Ejection Fraction and Symptoms of Heart Failure. MERIT, SH-MET 0024, #830-30. (1997-Completed).
CONVINCE, “Controlled Onset Verapamil Investigation of Cardiovascular Endpoints”: IND #39.459, I26-96-02-011. (1996-2001).
RENAAL, “A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients with NIDDM and Nephropathy” (MERCK PROTOCOL 147). (1996-2001)
AZIMILIDE,“An Open-Label Clinical Trial to Assess the Long Term Safety of Azimilide in Patients with Atrial Fib/Flutter and/or Paroxysmal Supraventricular Tachycardia” # 1995011. (1995-Completed).
TRANDOLAPRIL in HYPERTENSION, Effectiveness When Added to Verapamil SR TARKA TV-48-HTN, (1995-1997).
A Double-Blind, Placebo-Controlled, Parallel, Design Clinical Trial to Assess the Safety and Efficacy of 100 Mg of Azimilide for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or symptomatic Paroxysmal Supraventricular Tachycardia No. 1995010 (1995-1997)
A Double-Blind, Randomized, Placebo-Controlled, Parallel Design Trial of Twelve to Fourteen weeks Duration to Determine the Effect of Food on Anti-hypertensive Response of CGP 48933 80-Mg in Patients with Mild to Moderate Essential Hypertension. (1993-1995).
Dose Ranging Study of Oral Bidsomide vs. Placebo in Reducing the Recurrence of Symptomatic Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachycardia NP8-92-02-046. (1993-1995).
CARDIZEM CD ANGINA STUDY, Protocol #DZPROI64. (1993).