None listed
Conditions
Interventions
Atenolol 50 mg and losartan placebo 50 mg for 16 weeks.
Group 1 Type of group
Losartan 50 mg and atenolol placebo 50 mg for 16 weeks.
Group name:Group 2 Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has recently been diagnosed with mild to moderate hypertension (PADSe> 90 mmHg 90 mmHg 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.
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Question 13 of the Health Assessment Questionnaire. The variable of primary efficacy will be the change from the baseline to the end of the treatment period (Week 16) with respect to the number of sexual intercourse in the period of the last 2 weeks. Measure:Number of sexual intercourse in the period of the last 2 weeks Timepoints:Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Question 13 of the Health Assessment Questionnaire. The variable of primary efficacy will be the change from the baseline to the end of the treatment period (Week 16) with respect to the number of sexual intercourse in the period of the last 2 weeks. Measure:If a patient had less sexual intercourse in the period of the last 2 weeks in Week 16 compared to the baseline Timepoints:Week 16 ; Outcome name:It is evaluated through the response (Its not a problem, Its a slight problem, In a way its a problem, Its a big problem, Its not applicable) for five sexual problems ( Lack of sexual interest, Inability to relax and enjoy sex, Difficulty getting sexually aroused, Difficulty achieving or maintaining an erection, Difficulty with ejaculation ) experienced during the previous 2 weeks Measure:Sexual performance score Timepoints:The previous 2 weeks ; Outcome name:(Question 11 of the Inventory of the Male Sexual Function of Oxeary: Question 14 of the Health Assessment Questionnaire) coded from 0 to 4. The change from the baseline to Week 16. Measure:Overall sexual satisfaction score Timepoints:Week 16 ; Outcome name:It is calculated based on the SF-36 survey (Version 1.0) contained in the Health Assessment Questionnaire Measure:Score of the Physical Component and Score of the Mental Component Timepoints:Week 16 ; Outcome name:The average of 3 consecutive measurements Measure:Diastolic and systolic blood pressure in sitting position Timepoints:Week 16 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed