RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC, MULTIFACTORIAL, PLACEBO-CONTROLLED, PARALLEL GROUP ASSESSMENT TO EVALUATE THE EFFICACY AND SAFETY OF VALSARTAN (160 MG AND 320 MG) AND AMLODIPINE (10 MG) ONLY AND IN COMBINATION IN PATIENTS WITH HYPERTENSIO
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-105-03
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Outpatients 18 years and older.
2. Patients of both sexes can participate. Women must be either postmenopausal for a year or hysterectomized, or use contraceptive methods recognized as the barrier method with spermicide or an intrauterine device. The use of hormonal contraceptives is not allowed.
3. Patients with essential diastolic hypertension determined by standard sphygmomanometer calibrated aneroid or mercury (preferable). Patients should have a PADMS> 90 mmHg and <110 mmHg at Visit 1 (week -4 to -2), and a PADMS> 95 mmHg and <110 mmHg at Visit 2 (week 0).
4. Between Visits 1 and 2, patients should have an absolute difference <10 mmHg in mean diastolic blood pressure in sitting position
5. Patients who are eligible to participate in the study and who give their consent after having received a clear explanation of the purpose and nature of the research (written informed consent).
1. Severe hypertension (PADMS> 110 mmHg and / or PASMS> 180 mmHg) at any time during the study.
2. Impossibility of safely discontinuing all antihypertensive medications
previous for a period of 14 weeks.
3. Keith-Wagener hypertensive retinopathy grade m or IV known.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method