An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
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ClinicalTrials.gov Identifier: NCT00384605 |
Recruitment Status
:
Terminated
(The overall profile does not support development for obesity)
First Posted
: October 6, 2006
Last Update Posted
: March 13, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: taranabant Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Arm 1: MK0364 2 mg capsule once daily
|
Drug: taranabant
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
|
Experimental: 2
Arm 2: MK0364 1 mg capsule once daily
|
Drug: taranabant
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
|
Experimental: 3
Arm 3: MK0364 0.5 mg capsule once daily.
|
Drug: taranabant
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
|
Placebo Comparator: 4
Arm 4: Pbo capsule once daily.
|
Drug: placebo
Placebo capsule once daily. Treatment for 52 weeks.
|
- Body weight after 52 weeks of treatment [ Time Frame: 52 weeks ]
- Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment [ Time Frame: 52 weeks ]

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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:
- Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
- Stable weight (+/-3 kg) for at least 3 months prior to study start
Exclusion Criteria:
- History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
- Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

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): NCT00384605
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00384605 History of Changes |
Other Study ID Numbers: |
0364-037 2006_513 |
First Posted: | October 6, 2006 Key Record Dates |
Last Update Posted: | March 13, 2015 |
Last Verified: | March 2015 |
Additional relevant MeSH terms:
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |