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Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01011725
First received: November 10, 2009
Last updated: August 9, 2016
Last verified: February 2016

November 10, 2009
August 9, 2016
November 2005
April 2006   (final data collection date for primary outcome measure)
  • Number of Participants with Serious Clinical Adverse Events [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Number of Participants with Nonerserious Clinical Adverse Events [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Number of Participants with Serious Laboratory Adverse Events [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Number of Participants with Nonserious Laboratory Adverse Events [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Due to Any Adverse Event [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Withdrew Consent and Discontinued the Study [ Time Frame: From date of enrollment through 12 weeks of study ] [ Designated as safety issue: Yes ]
  • Least Squares Mean Change in Lean Body Mass [ Time Frame: From baseline, at 12 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Serious CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Laboratory Adverse Events (LAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01011725 on ClinicalTrials.gov Archive Site
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Not Provided
 
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: MK 0773
    25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
  • Drug: Placebo
    Placebo oral tablet b.i.d for 12 weeks
  • Experimental: Postmenopausal Women- Active Agent Group
    Intervention: Drug: MK 0773
  • Placebo Comparator: Postmenopausal Women- Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2009
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is a nonsurgical postmenopausal female
  • Subject is neither grossly overweight nor underweight for her height
  • Subject is in good health
  • Subject is willing to avoid excess alcohol and strenuous physical activity during the study
  • Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study

Exclusion Criteria:

  • Subject has significant drug allergies
  • Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
  • Subject is a regular user or past abuser of any illicit drug (including alcohol)
  • Subject drinks excessive amounts of caffeinated beverages
  • Subject has a history of cancer
Female
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01011725
0773-003, MK0773-003
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2016

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