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Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

NCT02040311 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2014-01-20

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of topiramate (96 mg or 192 mg daily) as compared to placebo in maintaining weight loss in obese subjects who participated in an eight week intensive non-pharmacologic weight loss program.

The primary efficacy endpoint will be the percent change in body weight from enrollment visit to week 60.

Conditions

Interventions

DRUG

Topiramate 96 mg daily

DRUG

Topiramate 192 mg daily

DRUG

Placebo

Sponsors & Collaborators

  • R W Johnson Pharmaceutical Research Institute

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Arne V Astrup, phD.MD · Department of Human Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040311 on ClinicalTrials.gov