MULTICENTER, RANDOMIZED, DOUBLE-BLIND, WITH DOUBLE SIMULATION, OF PARALLEL GROUPS, STUDY TO EVALUATE THE EFFECTIVENESS OF VALSARTAN 320 MG / HYDROCHLOROTHIAZIDE 12.5 MG VERSUS ENALAPRIL 20 MG / HYDROCHLOROTIZIDE 12.5 MG ON THE MEDIUM SYSTOLIC ARTERIAL PRESSURE IN POSITION SITTED IN PATIENTS WITH HYPERTENSION MODERATE
Not Applicable
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-090-04
- 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
Inclusion Criteria
• Patients of both sexes> 18 years of age
• Mean SBP> 160 mmHg in Visits 1 and 2, for untreated patients. Patients who are receiving antihypertensive medication in Visit 1 should not have their blood pressure controlled (ie, mean BP> 140/90 mmHg). By treated patients are meant those patients who take medication up to 2 days before Visit 1
• All patients must have a PASMS> 160 mmHg at Visit 3.
Exclusion Criteria
• PASMS> 180 mmHg and / or PADMS> 110 mmHg at any time between Visit 1 and Visit 3.
• History of hypertensive encephalopathy, stroke, ischemic attack
• Percutaneous coronary intervention (PCI), or Myocardial Revascularization Surgery.
• Diabetes mellitus type 2 uncontrolled, ie HbA1c> 8.5%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:difference between the average of 3 readings made in Visit 7 (or at the time of the premature discontinuation) and the average of 3 readings made in the basal period (Visit 3).<br>Measure:Change in PASMS after the study is finished<br>Timepoints:11 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Calculated by averaging the available hourly means), to compare valsartan versus enalapril between the end of the study (Visit 7) and the basal period (Visit 3)<br>Measure:Mean 24-hour ambulatory systolic BP<br>Timepoints:Visits 3 and 7<br>;<br>Outcome name:Calculated by averaging the available hourly averages, to compare valsartan versus enalapril between the end of the study (Visit 7) and the baseline period (Visit 3)<br>Measure:Average 24-hour ambulatory diastolic BP<br>Timepoints:Visits 3 and 7<br>;<br>Outcome name:Calculated by averaging the available daytime and night time averages to compare valsartan versus enalapril between the end of the study (Visit 7) and the baseline period (Visit 3)<br>Measure:Average daily and night ambulatory BP<br>Timepoints:Visits 3 and 7<br>