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Health Assessment Study (0954-946)

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: NCT00541684
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date April 12, 2017
Actual Study Start Date  ICMJE July 11, 2001
Actual Primary Completion Date January 23, 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
number of sexual intercourse events in a 2-week period [ Time Frame: 2 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
sexual functioning score and overall sexual satisfaction score after 16 weeks [ Time Frame: 16 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Assessment Study (0954-946)
Official Title  ICMJE A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
Brief Summary The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: MK0954, /Duration of Treatment : 16 Weeks
  • Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
143
Original Enrollment  ICMJE
 (submitted: October 5, 2007)
126
Actual Study Completion Date  ICMJE January 23, 2003
Actual Primary Completion Date January 23, 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed with mild to moderate hypertension\
  • Married male in stable heterosexual relationship
  • No prior history of sexual dysfunction
  • Satisfied with overall sex life
  • Patient's spouse is in close proximity for the study
  • Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
  • Patient able to visit doctor in the morning of each scheduled visit
  • Able to complete the self administered health assessment questionnaire

Exclusion Criteria:

  • Hypertension due to cancer, history of heart or circulatory problems
  • History of mental disorder that might impair sexual function
  • History or presence of drug or alcohol abuse
  • Prior surgery for erectile dysfunction or other urological procedure
  • No penile implant or assist devices
  • History of chronic liver disease, history of diabetes
  • History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
  • Subjects with only 1 kidney
  • Mental handicap or legal incapacity
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541684
Other Study ID Numbers  ICMJE 0954-946
2007_624
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2017

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