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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arm 1: MK0364 2 mg capsule once daily

Group Type EXPERIMENTAL

taranabant

Intervention Type DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

2

Arm 2: MK0364 1 mg capsule once daily

Group Type EXPERIMENTAL

taranabant

Intervention Type DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

3

Arm 3: MK0364 0.5 mg capsule once daily.

Group Type EXPERIMENTAL

taranabant

Intervention Type DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

4

Arm 4: Pbo capsule once daily.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo capsule once daily. Treatment for 52 weeks.

Interventions

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taranabant

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

Intervention Type DRUG

placebo

Placebo capsule once daily. Treatment for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No