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MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY, IN PARALLEL GROUPS, WITH ACTIVE CONTROL, OF 24 WEEKS OF DURATION, TO EVALUATE THE EFFICACY OF THE COMBINATION VALSARTAN / HYDROCHLOROTHYAZIDE VERSUS AMLODIPINE ON THE SYSTOLIC ARTERIAL PRESSURE IN PATIENTS WITH MODERATE HYPERTENSION WITH RISK FACTORS AND / OR CARDIOVASCULAR CONCOMYANT DISEASE

MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY, IN PARALLEL GROUPS, WITH ACTIVE CONTROL, OF 24 WEEKS OF DURATION, TO EVALUATE THE EFFICACY OF THE COMBINATION VALSARTAN / HYDROCHLOROTHYAZIDE VERSUS AMLODIPINE ON THE SYSTOLIC ARTERIAL PRESSURE IN PATIENTS WITH MODERATE HYPERTENSION WITH RISK FACTORS AND / OR CARDIOVASCULAR CONCOMYANT DISEASE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-010-03
Enrollment
10
Registered
2003-02-25
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

Valsartan 160 mg / Hydrochlorothiazide 25 mg Type of group
Valsartan 160 mg / Hydrochlorothiazide 25 mg will be administered. Patients will be followed for another 20 weeks with that treatment regimen. Group name:Amlodipine 10 mg Type of group
Amlodipine 10 mg will be administered. Patients will be followed for another 20 weeks with that treatment regimen.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male patients or women> 18 years of age with moderate hypertension defined by an MSSBP of> 160 mmHg and a pulse pressure> 70 mmHg in Visits 1, 2 and 3 for untreated patients. Patients currently treated with antihypertensives, who continue uncontrolled (ie, MSSBP> 140 mmHg) with treatment and who have a blood pressure of 160 mmHg and a pulse pressure> 70 mmHg at Visit 3.

Exclusion criteria

Exclusion criteria: 1. MSSBP> 190 mmHg and / or MSDBP> 110 mmHg at any time from Visit 1 to Visit 3. 2. Impossibility to discontinue all previous antihypertensive medication safely during a period of three weeks. 3. Mandatory indication of any concomitant medication that is not allowed in the study. 4. Women patients who have not been post-menopausal for a year or who are not surgically sterilized and who are not using an effective contraceptive method, such as barrier methods with spermicides or intrauterine devices. The use of oral contraceptives or dermal implants as the only method of contraception is not allowed. 5. Keith-Wagener grade III or IV known hypertensive retinopathy. 6. History of hypertensive encephalopathy or stroke less than 1 year before Visit 1.

Design outcomes

Primary

MeasureTime frame
Outcome name:Mean systolic pressure in sitting position Measure:superiority of valsartan / HCTZ over amlodipine. Timepoints:4 week—

Secondary

MeasureTime frame
Outcome name:Serum markers of endothelial function + inflammation Measure:Changes with respect to baseline values in circulating markers of endothelial dysfunction and vascular inflammation. Timepoints:4 week—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)