Text Size

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:
Merck
ClinicalTrials.gov Identifier:
NCT00420589
First received: January 5, 2007
Last updated: March 6, 2013
Last verified: March 2013
History of Changes

January 5, 2007
March 6, 2013
October 2006
February 2008   (final data collection date for primary outcome measure)
Body weight at 52 weeks, safety and tolerability. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Body weight at 52 weeks, safety and tolerability.
Complete list of historical versions of study NCT00420589 on ClinicalTrials.gov Archive Site
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
Not Provided
Not Provided
 
A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)
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

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Obesity
  • Drug: taranabant
    taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
  • Drug: Comparator: placebo
    Placebo capsules once daily. Treatment for 52 weeks
  • Placebo Comparator: 1
    Arm 1: MK0364 Pbo capsules once daily
    Intervention: Drug: Comparator: placebo
  • Experimental: 2
    Arm 2: MK0364 0.5 mg capsule once daily
    Intervention: Drug: taranabant
  • Experimental: 3
    Arm 3: MK0364 1 mg capsule once daily
    Intervention: Drug: taranabant
  • Experimental: 4
    Arm 4: MK0364 2 mg capsule once daily
    Intervention: Drug: taranabant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1000
November 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00420589
MK-0364-012, 2006_512
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP