A Weight Maintenance Study in Obese Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00420589

Purpose

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension

Resource links provided by NLM:

MedlinePlus related topics: Diets Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Body weight at 52 weeks, safety and tolerability. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	1000
Study Start Date:	October 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Arm 1: MK0364 Pbo capsules once daily	Drug: Comparator: placebo Placebo capsules once daily. Treatment for 52 weeks
2: Experimental Arm 2: 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.
3: Experimental Arm 3: 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.
4: Experimental Arm 4: 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
Patient is male or female >=18 and <= 65 years of age
Patient understands the study procedures and alternative treatments available
Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

Patient has a history or presence of a major psychiatric disorder
Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
Patient has a history of seizures or is at high risk of developing seizures
Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
Patient has diabetes mellitus as defined by medical history

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420589

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_512, MK0364-012
Study First Received:	January 5, 2007
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00420589 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Weight loss
Weight regain
Weight maintenance

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 09, 2009