A Study of MK0364 in Obese Patients (0364-014)
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ClinicalTrials.gov Identifier: NCT00131391 |
Recruitment Status
:
Terminated
(The overall profile does not support development for obesity)
First Posted
: August 18, 2005
Last Update Posted
: April 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: Comparator: taranabant Drug: Comparator: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | December 2008 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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.
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Drug: Comparator: placebo
Placebo capsule once daily . 52 week treatment period.
|
Experimental: 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.
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Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
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Experimental: 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.
|
Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
Drug: Comparator: placebo
Placebo capsule once daily . 52 week treatment period.
|
Experimental: 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.
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Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
|
Experimental: 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.
|
Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
|
Experimental: 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.
|
Drug: Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Other Name: MK0364
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- Decreases body weight; prevention of weight regain; safety and tolerability [ Time Frame: 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 [ Time Frame: 2 Years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Body Mass Index (BMI) between 30-43 kg/m2
Exclusion Criteria:
- History of major psychiatric disorder
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131391
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00131391 History of Changes |
Other Study ID Numbers: |
0364-014 2005_034 |
First Posted: | August 18, 2005 Key Record Dates |
Last Update Posted: | April 3, 2015 |
Last Verified: | April 2015 |