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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00420589
Recruitment Status : Terminated (The overall profile does not support development for obesity)
First Posted : January 11, 2007
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Drug: taranabant Drug: Comparator: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2006
Primary Completion Date : February 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Body weight at 52 weeks, safety and tolerability. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks. [ Time Frame: 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

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