The overall profile does not support development for obesity
A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension
Sponsor study identifier
Secondary identifiers
interventional
2,400
0 countries
N/A
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
December 2008
Actual (reported)A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 16, 2005
Actual (reported)August 18, 2005
Actual (reported)February 2008
Actual (reported)December 2008
Actual (reported)Decreases body weight; prevention of weight regain; safety and tolerability
2 Years
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
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.
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.
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Medical Monitor
Merck Sharp & Dohme LLC
2,400 participants (actual enrollment reported by the registry).
First Submitted
August 16, 2005
First Posted
August 18, 2005
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
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.
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.
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: 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.
Placebo capsule once daily . 52 week treatment period.
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
April 3, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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