DOUBLE BLIND, RANDOM, TWO ARM, PARALLEL STUDY WITH LOSARTAN OR ATENOLOL FOR THE EVALUATION OF THE HEALTH OF PATIENTS WITH MILD TO MODERATE HYPERTENSIO
- Conditions
- -I10 Essential (primary) hypertension-F529 Unspecified sexual dysfunction, not caused by organic disorder or diseaseUnspecified sexual dysfunction, not caused by organic disorder or diseaseEssential (primary) hypertensionF529I10
- Registration Number
- PER-032-01
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient has recently been diagnosed with mild to moderate hypertension (PADSe> 90 mmHg <109 mmHg) before starting therapy with the placebo of the basal drug (Visit 1).
• The patient has a PADSe> 90 mmHg <109 mmHg before starting active treatment at Visit 2.
• The patient´s age is> 40 and <49 years.
• The patient is a married man who maintains a stable heterosexual relationship, has no history of sexual dysfunction and has been satisfied with his sexual life in general.
• The patient´s spouse normally stays close to the patient (does not take long trips or take long vacations) during the study.
• The patient has had sexual intercourse at least 2 times, but not more than 10, during a period of two weeks before Visit 1.
• The patient can go to the doctor in the morning for each of the scheduled visits and complete the health assessment questionnaire that each individual completes.
• The Patient´s PASSe is> 180 mmHg at Visit 1, 2 or on any subsequent visit, the patient should be discontinued.
• Patient PADSe is not properly controlled (PADSe> 110 mmHg) during active treatment, the patient should be discontinued from the study.
• Secondary hypertension of any etiology, for example, unilateral or bilateral nephropathy, stenosis of the renal artery, stenosis of the isthmus of the aorta or pheochromocytoma.
• Malignant hypertension.
• History of cerebrovascular disease or transient ischemic attacks within the last six months.
• Patients with a history of myocardial infarction within the last six months.
• The patient suffers from chest pain of any etiology.
• The patient suffers from coronary heart disease.
• The patient presents arrhythmias or clinically significant conduction disturbances.
• Arylends of undefined syncope or presence of a known disease associated with syncope (eg, Adams-Stokes disease).
• History or presence of heart failure or a left ventricular ejection fraction of <40%.
• Hemodynamically significant obstructive valve disease or hypertrophic cardiomyopathy.
• Percutaneous coronary angioplasty or bypass surgery of the coronary within the last six months. Patients with a less recent operation or PTCA may be included if they are in a stable condition with respect to health and medication.
• Clinically significant peripheral vascular disease, which could pose a risk to the patient during therapy with a beta-blocker.
• Any lung disease that represents a contraindication to atenolol, such as asthma.
• Neurological diseases that at the discretion of the researcher would damage sexual function.
• Has a history or currently manifests abuse of alcohol or drugs.
• The patient underwent surgery of the penis, prostate or pelvis due to erectile dysfunction or some invasive urological procedure.
• Patients with penile implants or assistive devices (inflatable balloons, rigid prostheses).
• The concurrent and continuous use of agents that could affect blood pressure (the use of beta-blockers is allowed for ophthalmological preparations).
• The concurrent use of substances with an important psychotropic action, for example, phenothiazine or chronic antidepressants.
• Treatment with the H2 receptor antagonist, cimetidine, (the use of famotidine and ranitidine is accepted).
• Regular use of NSAIDs. The use of aspirin in low doses (<325 mg / day) for cardiac protection is accepted.
• Concomitant treatment with steroids, ACTH, lithium or any drug that may impair sexual function.
• Treatment with a drug known to affect sexual function, such as diuretics for edema, or alternative therapies, such as medicines / remedies based on yohimbine and herbs.
• Patients have some evidence of significant renal or hepatic dysfunction according to their medical history or a laboratory test that has recently been performed.
• Any evidence of significant deviations in laboratory values from the normal range, including, without limitations, hematocrit, hemoglobin, platelet count, and white blood cell count.
• Serum potassium <3.5 or> 5.5 mval / 1 (mEq / 1).
• Some hematuria of unknown etiology.
• History or presence of clinically significant malabsorption syndrome or gastrointestinal resection.
• History of chronic liver disease.
• Patient with diabetes.
• Other severe concomitant diseases tha
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method