NCT00000506

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 1983

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1983

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1988

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Heart DiseasesObesityVascular Diseases

Interventions

fenfluramineDRUG
phentermineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (9)

  • 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. doi: 10.1038/clpt.1992.68. No abstract available.

    PMID: 1445528BACKGROUND

  • 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. doi: 10.1038/clpt.1992.69.

    PMID: 1587072BACKGROUND

  • 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. doi: 10.1038/clpt.1992.70.

    PMID: 1587073BACKGROUND

  • 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. doi: 10.1038/clpt.1992.71.

    PMID: 1587074BACKGROUND

  • 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. doi: 10.1038/clpt.1992.72.

    PMID: 1587075BACKGROUND

  • 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. doi: 10.1038/clpt.1992.73.

    PMID: 1587076BACKGROUND

  • 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. doi: 10.1038/clpt.1992.74.

    PMID: 1587077BACKGROUND

  • 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. doi: 10.1038/clpt.1992.75.

    PMID: 1587078BACKGROUND

  • Weintraub M. Long-term weight control study: conclusions. Clin Pharmacol Ther. 1992 May;51(5):642-6. doi: 10.1038/clpt.1992.76. No abstract available.

    PMID: 1587079BACKGROUND

MeSH Terms

Conditions

Heart DiseasesObesityVascular Diseases

Interventions

FenfluraminePhentermine

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsAmphetamines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

May 1, 1983

Study Completion

April 1, 1988

Last Updated

November 26, 2013

Record last verified: 2000-01