Cardiovascular System in Obesity: Effect of Treatment - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000506

Purpose

To determine the long-term efficacy of the combination therapy of phentermine and fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment of simple, moderate obesity.

Condition	Intervention	Phase
Heart Diseases Obesity Vascular Diseases	Drug: fenfluramine Drug: phentermine	Phase II

MedlinePlus related topics: Heart Diseases Obesity Vascular Diseases

Drug Information available for: Phentermine Phentermine hydrochloride Fenfluramine Fenfluramine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Parallel Assignment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

May 1983

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Weintraub M. Long-term weight control: the National Heart, Lung, and Blood Institute funded multimodal intervention study. Clin Pharmacol Ther. 1992 May;51(5):581-5. No abstract available.

Weintraub M, Sundaresan PR, Madan M, Schuster B, Balder A, Lasagna L, Cox C. Long-term weight control study. I (weeks 0 to 34). The enhancement of behavior modification, caloric restriction, and exercise by fenfluramine plus phentermine versus placebo. Clin Pharmacol Ther. 1992 May;51(5):586-94.

Weintraub M, Sundaresan PR, Schuster B, Ginsberg G, Madan M, Balder A, Stein EC, Byrne L. Long-term weight control study. II (weeks 34 to 104). An open-label study of continuous fenfluramine plus phentermine versus targeted intermittent medication as adjuncts to behavior modification, caloric restriction, and exercise. Clin Pharmacol Ther. 1992 May;51(5):595-601.

Weintraub M, Sundaresan PR, Schuster B, Moscucci M, Stein EC. Long-term weight control study. III (weeks 104 to 156). An open-label study of dose adjustment of fenfluramine and phentermine. Clin Pharmacol Ther. 1992 May;51(5):602-7.

Weintraub M, Sundaresan PR, Schuster B, Averbuch M, Stein EC, Cox C, Byrne L. Long-term weight control study. IV (weeks 156 to 190). The second double-blind phase. Clin Pharmacol Ther. 1992 May;51(5):608-14.

Weintraub M, Sundaresan PR, Schuster B, Averbuch M, Stein EC, Byrne L. Long-term weight control study. V (weeks 190 to 210). Follow-up of participants after cessation of medication. Clin Pharmacol Ther. 1992 May;51(5):615-8.

Weintraub M, Sundaresan PR, Cox C. Long-term weight control study. VI. Individual participant response patterns. Clin Pharmacol Ther. 1992 May;51(5):619-33.

Weintraub M, Sundaresan PR, Schuster B. Long-term weight control study. VII (weeks 0 to 210). Serum lipid changes. Clin Pharmacol Ther. 1992 May;51(5):634-41.

Weintraub M. Long-term weight control study: conclusions. Clin Pharmacol Ther. 1992 May;51(5):642-6. No abstract available.

Study ID Numbers:	25
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000506
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Heart Diseases
Vascular Diseases
Nutrition Disorders

Overweight
Overnutrition
Fenfluramine
Serotonin
Phentermine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Serotonin Uptake Inhibitors
Pharmacologic Actions

Anti-Obesity Agents
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Appetite Depressants
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009