A Study of MK0364 in Obese Patients (0364-014)

NCT ID: NCT00131391

Last Updated: 2015-04-03

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

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-12-31

Brief Summary

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A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

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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Phase A/B; Arm 1

Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

Placebo capsule once daily . 52 week treatment period.

Phase A/B: Arm 2

Phase A: Arm 2: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily.

Group Type EXPERIMENTAL

Comparator: taranabant

Intervention Type DRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Phase A/B: Arm 3

Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily.

Group Type EXPERIMENTAL

Comparator: taranabant

Intervention Type DRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Comparator: placebo

Intervention Type DRUG

Placebo capsule once daily . 52 week treatment period.

Phase A/B: Arm 4

Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily.

Group Type EXPERIMENTAL

Comparator: taranabant

Intervention Type DRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Phase A/B: Arm 5

Phase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily.

Group Type EXPERIMENTAL

Comparator: taranabant

Intervention Type DRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Phase A/B: Arm 6

Phase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily.

Group Type EXPERIMENTAL

Comparator: taranabant

Intervention Type DRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Interventions

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Comparator: taranabant

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Intervention Type DRUG

Comparator: placebo

Placebo capsule once daily . 52 week treatment period.

Intervention Type DRUG

Other Intervention Names

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MK0364

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria

* History of major psychiatric disorder
* History of seizures or at high risk of developing seizures
* Blood pressure greater than 160/100
* Fasting blood glucose greater than 126 mg/dL
* Triglycerides greater than 600 mg/dL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2005_034

Identifier Type: -

Identifier Source: secondary_id

0364-014

Identifier Type: -

Identifier Source: org_study_id

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