A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(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:
NCT00131404
First received: August 16, 2005
Last updated: March 5, 2014
Last verified: March 2014

August 16, 2005
March 5, 2014
September 2005
February 2007   (final data collection date for primary outcome measure)
Decreases body weight; safety and tolerability [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00131404 on ClinicalTrials.gov Archive Site
Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]
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A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)
A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

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: taranabant
    taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 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 Phase B will remain in the same arm they were assigned to during Phase 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 2 mg capsule once daily.

    Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.

    Intervention: Drug: taranabant
  • Experimental: Phase A/B: Arm 3

    Phase A: Arm 3: MK0364 4 mg capsule once daily.

    Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3:

    MK0364 4 mg capsule once daily.

    Intervention: Drug: taranabant
  • Experimental: Phase A/B: Arm 4

    Phase A: Arm 4: MK0364 6 mg capsule once daily.

    Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4:

    MK0364 6 mg capsule once daily.

    Intervention: Drug: taranabant
  • Experimental: Phase A/B: Arm 5
    Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.
    Intervention: Drug: taranabant
Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.

*   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 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea

Exclusion Criteria:

  • Patients with serious or unstable current or past medical conditions
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00131404
0364-015, 2005_031
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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