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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_034 |
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The overall profile does not support development for obesity
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A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.
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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 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. |
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| Phase A/B: Arm 2 | Experimental | 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. |
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| Phase A/B: Arm 3 | Experimental | 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. |
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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 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. |
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| Phase A/B: Arm 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: taranabant | Drug | taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Decreases body weight; prevention of weight regain; safety and tolerability | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity | 2 Years |
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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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| 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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| Experimental |
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. |
|
| Phase A/B: Arm 6 | Experimental | 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. |
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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 |