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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

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.
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.
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 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.
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



Primary Outcome Measures :
  1. Decreases body weight; prevention of weight regain; safety and tolerability [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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