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

This study has been terminated.
(The overall profile does not support development for obesity)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00131391
First received: August 16, 2005
Last updated: May 28, 2013
Last verified: May 2013

August 16, 2005
May 28, 2013
July 2005
February 2008   (final data collection date for primary outcome measure)
Decreases body weight; prevention of weight regain; safety and tolerability [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00131391 on ClinicalTrials.gov Archive Site
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 ]
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A Study of MK0364 in Obese Patients (0364-014)(TERMINATED)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • 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.
  • 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.
    Intervention: Drug: Comparator: placebo
  • 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.
    Intervention: Drug: Comparator: taranabant
  • 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.
    Interventions:
    • Drug: Comparator: taranabant
    • Drug: Comparator: placebo
  • 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.
    Intervention: Drug: Comparator: taranabant
  • 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.
    Intervention: Drug: Comparator: taranabant
  • 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.
    Intervention: Drug: Comparator: taranabant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2400
December 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00131391
MK-0364-014, 2005_034
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2013

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