FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-090-04
Enrollment
Unknown
Registered
2005-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
Valsartan 160 mg / HCTZ 12.5 mg for 4 weeks Group name:Group 2 Type of group
Enalapril 10 mg / HCTZ 12.5 mg for 4 weeks

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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%

Design outcomes

Primary

MeasureTime frame
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). Measure:Change in PASMS after the study is finished Timepoints:11 weeks—

Secondary

MeasureTime frame
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) Measure:Mean 24-hour ambulatory systolic BP Timepoints:Visits 3 and 7 ; 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) Measure:Average 24-hour ambulatory diastolic BP Timepoints:Visits 3 and 7 ; 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) Measure:Average daily and night ambulatory BP Timepoints:Visits 3 and 7—

Outcome results

None listed

Source: REPEC (via WHO ICTRP)