Health Assessment Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00541684

Purpose

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	Intervention	Phase
Hypertension	Drug: MK0954, /Duration of Treatment : 16 Weeks Drug: Comparator : atenolol /Duration of Treatment : 16 Weeks	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atenolol

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

number of sexual intercourse events in a 2-week period [ Time Frame: 2 Weeks ]

Secondary Outcome Measures:

sexual functioning score and overall sexual satisfaction score after 16 weeks [ Time Frame: 16 Weeks ]

Estimated Enrollment:	126
Study Start Date:	April 2001
Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	40 Years to 49 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541684

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00541684 History of Changes
Other Study ID Numbers:	2007_624
Study First Received:	October 5, 2007
Last Updated:	September 23, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics

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

ClinicalTrials.gov processed this record on February 09, 2012