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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_031 |
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The overall profile does not support development for obesity
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A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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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. |
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| 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. |
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| Phase A/B: Arm 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taranabant | Drug | taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Decreases body weight; safety and tolerability | 156 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity | 156 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20157323 | Result | Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C521311 | N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide |
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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. |
|
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| Comparator: Placebo | Drug | Placebo capsule once daily. 52 week treatment period. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |