A Study of MK0364 in Obese Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00131391

Purpose

A two year worldwide study in obese patients to assess the efficacy, safety and tolerability of MK0364.

Condition	Intervention	Phase
Obesity	Drug: taranabant Drug: Comparator: placebo (unspecified)	Phase III

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 MK0364 in Obese Patients

Further study details as provided by Merck:

Primary Outcome Measures:

Decreases body weight; prevention of weight regain; safety and tolerability [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	2400
Study Start Date:	March 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase A/B; Arm 1: Placebo Comparator 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period. Drug: Comparator: placebo (unspecified) Placebo capsule once daily . 52 week treatment period.
Phase A/B: Arm 2: Experimental 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Phase A/B: Arm 3 Phase A: Arm 3: MK-0364 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period. Drug: Comparator: placebo (unspecified) Placebo capsule once daily . 52 week treatment period.
Phase A/B: Arm 4: Experimental 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Phase A/B: Arm 5: Experimental 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
Phase A/B: Arm 6: Experimental 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: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131391

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_034, MK0364-014
Study First Received:	August 16, 2005
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00131391
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009