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An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

Primary Purpose

Obesity

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
taranabant
placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
  • Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion Criteria:

  • History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
  • Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Arm 1: MK0364 2 mg capsule once daily

    Arm 2: MK0364 1 mg capsule once daily

    Arm 3: MK0364 0.5 mg capsule once daily.

    Arm 4: Pbo capsule once daily.

    Outcomes

    Primary Outcome Measures

    Body weight after 52 weeks of treatment

    Secondary Outcome Measures

    Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment

    Full Information

    First Posted
    October 3, 2006
    Last Updated
    March 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00384605
    Brief Title
    An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
    Official Title
    A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    The overall profile does not support development for obesity
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Arm 1: MK0364 2 mg capsule once daily
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Arm 2: MK0364 1 mg capsule once daily
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Arm 3: MK0364 0.5 mg capsule once daily.
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    Arm 4: Pbo capsule once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    taranabant
    Intervention Description
    taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo capsule once daily. Treatment for 52 weeks.
    Primary Outcome Measure Information:
    Title
    Body weight after 52 weeks of treatment
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea Stable weight (+/-3 kg) for at least 3 months prior to study start Exclusion Criteria: History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

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