A Two Year Safety and Efficacy Study in Obese Patients - Full Text View

Purpose

A study to determine the safety and efficacy of an investigational drug in patients with obesity.

Condition	Intervention	Phase
Obesity and Obesity-Related Medical Conditions	Drug: taranabant Drug: Comparator: Placebo (unspecified)	Phase II

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 to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

Further study details as provided by Merck:

Primary Outcome Measures:

Decreases body weight; safety and tolerability [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2400
Study Start Date:	July 2005
Study Completion Date:	December 2007

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 Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.	Drug: Comparator: Placebo (unspecified) Placebo capsule once daily. 52 week treatment period.
Phase A/B: Arm 2: Experimental Phase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.	Drug: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Phase A/B: Arm 3: Experimental Phase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily.	Drug: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg 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 Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily.	Drug: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.
Phase A/B: Arm 5: Experimental Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.	Drug: taranabant taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 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:

Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea.

Exclusion Criteria:Patients with serious or unstable current or past medical conditions.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131404

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_031, MK0364-015
First Received:	August 16, 2005
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00131404
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00131404