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

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: MK0954, /Duration of Treatment : 16 Weeks Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
Actual Study Start Date : July 11, 2001
Primary Completion Date : January 23, 2003
Study Completion Date : January 23, 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol
U.S. FDA Resources

Primary Outcome Measures :
  1. number of sexual intercourse events in a 2-week period [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. sexual functioning score and overall sexual satisfaction score after 16 weeks [ Time Frame: 16 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541684

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00541684     History of Changes
Other Study ID Numbers: 0954-946
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action