Study Results
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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TERMINATED
PHASE3
2400 participants
INTERVENTIONAL
2005-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Comparator: placebo
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.
Comparator: taranabant
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.
Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Comparator: placebo
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.
Comparator: taranabant
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.
Comparator: taranabant
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.
Comparator: taranabant
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.
Comparator: placebo
Placebo capsule once daily . 52 week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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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