Clinical Trials

Medical Research Trials Performed by the Self Center

 

2008 – Orexigen Therapeutics, Inc.

Principal Investigator: “A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placeob-Controlled Safety and Efficacy Study of Zonisamide SR plus Bupropion SR Combination Therapy in Subjects with Obesity.”

Protocol #ZB-202 Phase IIB

 

2007 – Arena Pharmaceuticals, Inc.

Principal Investigator: "A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients.”

Protocol #APD356-011 52 Week Extention Phase III

 

2007 – Arena Pharmaceuticals, Inc.

Principal Investigator: "A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients.”

Protocol #APD356-011 Phase III

  

2007 – Orexigen Theraputics

Principal Investigator: “A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR) Bupropion Sustained Release (SR) and Placebo in Obese Subjects.”

Prototcol #NB-301 Phase III

 

2007 – Orexigen Theraputics

Principal Investigator: “ A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release (SR) Bupropion 360 mg Sustained Release (SR) and Placebo in Obese Subjects with Type 2 Diabetes Mellitus

Protocol # NB 304 Phase III

 

2006 – Merck & Company, Inc.

Principal Investigator: A Study to Assess the Efficacy and Tolerability of MK-0364 in Maintaining Weight Loss Induced by Diet in Obese Patients. Protocol 012

Protovol # MK-0364-012 Phase III

 

2006 – Pfizer Pharmaceuticals, Inc.

Principal Investigator: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase III Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

Protocol # A5351025 – 1010 Phase III

 

2006 – Arena Pharmaceuticals, Inc.

Principal Investigator: “A 104-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients.”

Protocol # APD356-009 Phase III

 

2006 - Boehringer Ingelheim Pharmaceuticals, Inc.

Principal Investigator: “A randomized, double-blind, double-dummy, placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage 1 or II hypertension, with an ABPM sub-study”

Protocol # 1235.1 – Phase III

 

2006 – Orexigen Therapeutics

Principal Investigator: “A Dose Parallel, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Multiple Regimens of the Combination of Zonisamide CR plus Bupropion SR in the Treatment of Subjects with Uncomplicated Obesity”

Protocol # ZB 201 Phase II

 

2006 – GlaxoSmithKline

Principal Investigator: “A randomized, double-blind, placebo-controlled, parallel-group, study evaluating the efficacy, safety, and duration of erection of flexible-dose vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and dyslipidemia”

Protocol SB-782528 Phase III

 

2006 - Phenomix Corporation

Principal Investigator: “A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Examine Safety and Establish Proof of Concept with PHX1149 in Patients with Type 2 Diabetes Mellitus”

Protocol # PHX1149-PROT201 Phase IIa

 

2005 – Novartis Pharmaceuticals

“A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment with Combination Therapy of LAF237 and Pioglitazone to LAF237 Monotherapy or Pioglitazone Monotherapy in Drug Naïve Patients with Type 2 Diabetes.”

Protocol #CLAF237A2355 Phase III

 

2004 – Novartis Pharmaceuticals

Principal Investigator: "An eight-week, randomized, double-blind, placebo controlled, Parallel-group, multicenter study comparing aliskiren 150 mg, 300 mg, and 600 mg to placebo in patients with essential hypertension.”

Protocol # CSPP100A2308 Phase III

 

2004 – Glaxo Smith Kline

Principal Investigator: “A Parallel, Six-Month, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study with a Double-Blind, Placebo-Controlled, Eighteen-Month Extension to Evaluate the Efficacy, Safety and Tolerability of Orally Administered GI181771X on Weight Loss in Overweight and Obese Subjects.”

Protocol #CKA20001 Amendment #3 Phase II

 

2003 – GlaxoSmithKline

Principal Investigator: “A Parallel, Six-Month, Double-blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered GI181771X on Weight Loss in Overweight and Obese Subjects.”

Protocol #CKA20001 Phase II

 

2003 - Novartis Pharmaceutical Corp

Principal Investigator: “A 12-week multicenter, uncontrolled, open-label forced titration study to investigate the efficacy and safety of valsartan (160 mg), valsartan (320mg), and valsartan (320 mg)/hydrochlorothiazide (12.5 mg) in the treatment of mild to moderate hypertensive subjects.”

Protocol #CVAL489A2419 Phase IVa

 

2003 – GlaxoSmithKline

Principal Investigator: “A 28 Day, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging. Phase IIa Study to Examine the Saety, Tolerability, and Effects of SB-480848 on LpPLA2 Activity in Dyslipidemic Patients.”

Protocol Number: SB-480848-005 Phase IIa

 

2003 – Merck & Co., Inc.

Principal Investigator: "A Double-Blind, Randomized, Active-Controlled MK-0767 and Meftformin Comparator Study in Type 2 Diabetic Patients inadequately Controlled on Diet and Exercise.”

Protocol Number: 020 IND #59,786 Phase III

 

2002 – Bertek Pharmaceuticals, Inc.

Principal Investigator: "A Double-Blind, Multi-Center, Randomized, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients with Mild To Moderate Hypertension.”

Protocol Number NEB-231 Phase III

 

2002 – Sanofi-Synthelabo

Principal Investigator: “A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter study of weight-reducing effect and safety of SR141716 in obese patients with type 2 diabetes.”

Protocol Number EFC4736 Phase III

 

2002 – Novartis Pharmaceuticals Corp.

Principal Investigator: “A Randomized, Multicenter, Double-Blind, Parallel group Study to Determine the Efficacy and Safety of LotrelÒ versus Enalapril in the Treatment of Hypertension in an African-American Population with Type 2 Diabetes.”

Protocol Number CCIB002FUS06 Phase III b

 

2002 – GlaxoSmithKline

Principal Investigator: “An Eight-Week, Parallel Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Two Formulations of Gl181771X, Each at Two Different Doses, in Obese Subjects.”

Protocol Number CKA20002 Phase II

 

2002 – Regeneron Pharmaceuticals, Inc.

Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of AXOKINEÒ Including 6 Months of Initial Drug Dosing, a 6-Month Off-Drug Treatment Period, and a 3-Month Re-Exposure Followed by a 3-Month Crossover in Overweight and Obese Subjects.”

Protocol Number AX15-OB-0109 Phase III

 

2001 – Regeneron Pharmaceuticals, Inc.

Principal Investigator: “A Phase III, 12-Month, Double Blind, Randomized, Parallel Group, Placebo Controlled, Efficacy and Safety Study of AXOKINEÒ in Overweight and Obese Subjects With a 12-Month Open-Label Extension Phase.”

Number AX15-OB-0008.00 Phase III

 

2001 – Schering-Plough Research Institute

Principal Investigator: “A Phase III, Multi-Center, Two-Arm Study to Asses the Efficacy and Safety of Ecopipam (SCH 39166) in the Treatment of Obesity in Subjects with Hypertension and/or Dyslipidemia.”

Protocol Number G-P01551 Phase II

 

2000 – BioStratum, Inc.

Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, MultiCenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral PyridorinÔ (pyridoxamine dihydrochloride) in Patients with Type 2 Diabetes and Diabetes-Associated Nephropathy.”

Protocol Number PYR 203 Phase IIb

 

2000 – BioStratum, Inc.

Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, MultiCenter, 52-Week Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral PyridorinÔ (pyridoxamine dihydrochloride) in Patients with Type 1 Diabetes and Diabetes-Associated Nephropathy.”

Protocol Number PYR 204 Phase II b

 

1999 – Glaxo Wellcome

Principal Investigator: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Tolerability and Efficacy of Oral 1555U88 (2.5 mg, 5 mg, 10 mg, or 15 mg per day) Compared to Placebo for the Treatment of Obesity in Subjects 18-65 Years of Age.”

Protocol Number OBS20001 Phase II

 

1998 - Hoffmann-La Roche

Principal Investigator: “A 52-Week, Multicenter, Randomized, Double- Blind, Placebo Controlled Study of The Efficacy Of Orlistat Treatment Plus Diet In Obese Patients With Type 2 Diabetic Patients Receiving Metformin.”

Protocol I.D M37048/NR15804B Version 3.0 Phase III

 

1998 - Merck & Co., Inc.

Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, Inpatient Study to Investigate the Safety, Tolerability and Antihypertensive Efficacy of a Multiple Dose Regimen of L-753,037 in African American Patients With Mild-to Moderate Hypertension.”

Protocol 009-00 Product: L-753,037 Phase II

 

1998 - Wyeth-Ayerst Research

Sub-Investigator: “Comparison of the Prevalence of Cardiac Valvular Abnormalities in Patients Treated with Fenfluramine and Phentermine in Combination for at Least Three Consecutive Months Versus Untreated Controls, as Assessed by Echocardiogram.”

Protocol Number 0927B2-916

 

1998 - Merck & Co., Inc.

Principal Investigator: “A Triple-blind, Randomized, Parallel, Efficacy Study of Losartan versus Irbesartan in Patients with Mild to Moderate Essential Hypertension.”

Protocol Number186-00/COZ44

 

1997 - Merck & Co., Inc.

Principal Investigator: "A double-blind, randomized, parallel effectiveness study of two hypertensive treatment regimens; losartan versus valsartan in patients with mild to moderate essential hypertension.”

MK-954 Protocol Number 174-00/COZ431-042.

 

1997 - Merck & Co., Inc.

Principal Investigator: "A prospective, Double Blind, Randomized, Parallel Study of the Effects Of The Non-steroidal Anti-inflammatory Drug Indomethacin on the Antihypertensive Response to Losartan versus Captopril in Patients With Essential Hypertension.”

Protocol Number NSAIDS 158-01

 

1996 - Merck & Co., Inc.

Principal Investigator: "A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes Mellitus and Nephropathy." (RENAAL)

Protocol Number MK-0954/Protocol Amendment Number 147-00

 

1996 - Dupont Merck Pharmaceutical Company

Sub-Investigator: "A Phase III Randomized Trial of Losoxantrone + Pacilitaxel + G-CSF Versus Paclitaxel Alone in Patients with Stage IV Breast Cancer."

Protocol Number: DUP 941-017 Phase III

 

1996 - Dey Laboratories, Inc.

Sub-Investigator " A 12 Week, Randomized, Double Blind, Positive Control, Cross over Study of Albuterol, Ipratropium, and the Combination, as an Inhalation Solution in Patients with Chronic Obstructive Pulmonary Disease"

Protocol Number DL-024

 

1996 - Abbott Laboratories

Sub-Investigator: "An Open Label Study of the Safety of Long Term Administration in patients with Epilepsy."

Protocol Number M91-604

 

1996 - Abbott Laboratories

Sub Investigator: "Safety & Efficacy of Tiagabine HCI as Adjunctive Treatment."

Protocol Number M92-825

 

1995 - Pfizer, Inc.

Principal Investigator: “A Randomized, Double Blind, Dose Titration, Parallel Group, Placebo Controlled Study to Evaluate the Effects of Amlodipine on Survival in Patients with Congestive Heart Failure."

(Praise II) Protocol Number 053-18

 

1995 - Rhone-Poulenc Rorer

Sub-Investigator: "Phase III, Randomized, Double-Blind, Multicenter Study of Synercid(R) (Quinupristin/Dalfopristin) vs. The Combination Ceftriazone + Erythromycin in the Treatment of Acute Community Acquired Bacterial Pneumonia.”

Protocol Number JRV 303 Phase III

 

1995 - Lorex Pharmaceuticals

Sub-Investigator: "Evaluation of the Efficacy and Safety of Eliprodil in Patients with Acute Ischemic Stroke."

Protocol # LES01 Incorp. Amendment 1 March 14, 1995

 

1995 - Merck Research Laboratories

Sub-Investigator: "A Parallel, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Effect of Adding 2.0% MK-507 Ophthalmic Solution to 0.5% TIMOPTIC-XE in Patient With Elevated Intraocular Pressure."

Protocol/Amendment Number 057-00/Multicenter

 

1995 - Merck Research Laboratories

Sub-Investigator: "Losartan Effectiveness and Tolerability Study (LET) A prospective, open-label randomized comparison of two treatment regimens: losartan or losartan/hydrochlorothiazide versus usual care in patients being treated for mild to moderate hypertension who need to switch drug therapy.” MK-954;

Protocol/Amendment Number 057-00/Multicenter

 

1995 - Merck Research Laboratories

Sub-Investigator: "Losartan Effectiveness and Tolerability Study (LET) A prospective, open-label randomized comparison of two treatment regimens: losartan or losartan/hydrochlorothiazide versus usual care in patients being treated for mild to moderate hypertension who need to switch drug therapy.” MK-954;

Protocol/Amendment Number COZ355 PR #127-00

 

1994 - Merck Research Laboratories

Principal Investigator: "A Multicenter, Double-blind. Randomized, Parallel, Captopril-controlled Study to Investigate the Safety and Tolerability of Losartan in Elderly Patients with Symptomatic Heart Failure.”

(ELITE) U.S. MK-0954 Protocol Number 097-00

 

1994 - Merck Research Laboratories

Sub-investigator: "Comparison Of Long-Term Effects Of Losartan And Captopril On Left Ventricular Dilatation And Function In Elderly Patients With Heart Failure - Rest Only Study.”

Losartan MK - 0954 Protocol Number: 097 Sub-Study

 

1994 - Merck Research Laboratories

Sub-investigator: "Evaluation Of Heart Rate Variability (HRV) In Elderly Patients With CHF And Comparison Of The Effects Of Losartan VS. Captopril on HRV Parameters."

MK - 0954 Protocol Number 097 Sub-Study

 

1994 - Self Center, P.C.

Principal Investigator: " A Single Blind Study of the Safety and Acceptability of Anorexiant Medications as Adjunct Therapy for Long term Treatment of Obesity."

Protocol Number SC-1

 

1992 - Miles Pharmaceutical

Co-Investigator: "A Double-Blind Placebo-Controlled Dose Scheduling Study of Bay w 6228 In Doses of 100 ug Twice Daily With Breakfast And Dinner Compared to 200 ug once Daily With Dinner Or At Bedtime In Patients With Hypercholesterolemia."

Protocol Number D91-016

 

1992 - Miles Pharmaceutical

Co Investigator: "A Double-Blind Dose-Ranging Study of Bay w 6228 In Doses of 25 ug, 50 ug, 100 ug and 200 ug Once Daily Compared To Placebo and Lovastatin 40 mg Once Daily In Patients With Hypercholesterolemia."

Protocol Number D91-031