A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

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:
NCT00420589
First received: January 5, 2007
Last updated: March 5, 2014
Last verified: March 2014
  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 3

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


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

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: November 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Arm 1: MK0364 Pbo capsules once daily
Drug: Comparator: placebo
Placebo capsules once daily. Treatment for 52 weeks
Experimental: 2
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.
Experimental: 3
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.
Experimental: 4
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
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: NCT00420589

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00420589     History of Changes
Other Study ID Numbers: 0364-012, 2006_512
Study First Received: January 5, 2007
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Weight loss
Weight regain
Weight maintenance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014