A Study of MK0364 in Obese Patients (0364-014)

This study has been terminated.

(The overall profile does not support development for obesity)

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00131391

First received: August 16, 2005

Last updated: April 2, 2015

Last verified: April 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: Comparator: taranabant Drug: Comparator: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Merck Sharp & Dohme Corp.:

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:	July 2005
Study Completion Date:	December 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00131391 History of Changes
Other Study ID Numbers:	0364-014 2005_034
Study First Received:	August 16, 2005
Last Updated:	April 2, 2015
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2016

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