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| Sponsored by: |
Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00131404 |
Purpose
A study to determine the safety and efficacy of an investigational drug in patients with obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity and Obesity-Related Medical Conditions |
Drug: taranabant Drug: Comparator: Placebo (unspecified) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension |
| Estimated Enrollment: | 2400 |
| Study Start Date: | July 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Phase A/B: Arm 1: Placebo Comparator
Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.
|
Drug: Comparator: Placebo (unspecified)
Placebo capsule once daily. 52 week treatment period.
|
|
Phase A/B: Arm 2: Experimental
Phase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.
|
Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
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|
Phase A/B: Arm 3: Experimental
Phase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily.
|
Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
|
|
Phase A/B: Arm 4: Experimental
Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily.
|
Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
|
|
Phase A/B: Arm 5: Experimental
Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.
|
Drug: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:Patients with serious or unstable current or past medical conditions.
-
Contacts and Locations More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2005_031, MK0364-015 |
| Study First Received: | August 16, 2005 |
| Last Updated: | December 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00131404 |
| Health Authority: | United States: Food and Drug Administration |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
