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A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia

Primary Purpose

Obesity, Hyperlipidemia, Hypertriglyceridemia

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Dyslipidemia, Hyperlipidemia, Triglyceride, HDL, LDL, Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2 Stable weight at least four months prior to the first enrollment visit Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL) Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) Exclusion Criteria: Contraindication or hypersensitivity to topiramate Pregnancy, nursing or women who plan to become pregnant during the study Enrollment fasting triglycerides <175 or >= 1000 mg/dL, and/or LDL >= 190 mg/dL Hyperlipidemia secondary to known disease Other significant medical conditions such as cardiovascular or liver disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.

    Secondary Outcome Measures

    Absolute change in body weight, body mass index, triglycerides, and absolute and percentage changes in cholesterol measures from baseline to Week 60. Safety evaluations throughout study.

    Full Information

    First Posted
    September 30, 2005
    Last Updated
    June 6, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231621
    Brief Title
    A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, One-year Study of the Efficacy and Safety of Topiramate in the Treatment of Obese Subjects With Dyslipidemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study was terminated prior to completion to focus on the development of a controlled release formulation.
    Study Start Date
    May 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia.
    Detailed Description
    Topiramate is not approved for the treatment of obesity. Studies have shown that topiramate reduces weight in obese patients with or without Type 2 diabetes, and may have the adjunctive benefit of reducing triglyceride and cholesterol levels in these patients. This double-blind, placebo controlled study evaluates the long-term efficacy of topiramate for reduction of weight and triglyceride levels in obese patients with borderline to high hypertriglyceridemia, and the safety and tolerability of topiramate in this patient population. The study consists of four phases: 4-week enrollment (screening) phase, 8-week titration phase (topiramate dose will be increased from 16mg/day to the assigned dose), 52-week maintenance phase, and 6-week follow-up. Effectiveness of topiramate will be evaluated by multiple measurements such as change in body weight, body mass index, fasting serum triglyceride levels, cholesterol and other lipid profiles. Safety evaluations will include incidence/severity of adverse events, vital signs, clinical laboratory results. The hypothesis is that topiramate as compared to placebo will provide a greater percent reduction in body weight and in fasting serum triglycerides from Week 0 (baseline) to Week 60. After the initial 8-weeks titration phase, the patients will be randomized to receive either 96mg (48mg twice daily) or 192mg (96mg twice daily) topiramate or placebo (twice daily) by mouth for 52 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Hyperlipidemia, Hypertriglyceridemia
    Keywords
    Obesity, Dyslipidemia, Hyperlipidemia, Triglyceride, HDL, LDL, Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    179 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.
    Secondary Outcome Measure Information:
    Title
    Absolute change in body weight, body mass index, triglycerides, and absolute and percentage changes in cholesterol measures from baseline to Week 60. Safety evaluations throughout study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2 Stable weight at least four months prior to the first enrollment visit Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL) Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) Exclusion Criteria: Contraindication or hypersensitivity to topiramate Pregnancy, nursing or women who plan to become pregnant during the study Enrollment fasting triglycerides <175 or >= 1000 mg/dL, and/or LDL >= 190 mg/dL Hyperlipidemia secondary to known disease Other significant medical conditions such as cardiovascular or liver disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=542&filename=CR003730_CSR.pdf
    Description
    A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects with Dyslipidemia

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