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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 HYPERTENSION

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 HYPERTENSION

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-105-03
Enrollment
122
Registered
2004-02-27
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 Type of group
Valsartan 160 mg will be administered for 8 weeks. Group name:Valsartan / Amiodipine 320/10 mg Type of group
Valsartan / Amiodipine 320/10 mg will be administered for 8 weeks.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Outcome name:blood pressure Measure:hypotensive effects of a regimen of a single daily administration of several combinations of valsartan (160 and 320 mg) and amlodipine (10 mg), compared to its components as monotherapy and placebo, in patients with uncomplicated diastolic essential hypertension (patients should have an average blood pressure in sitting position [PADMS]> 95 mmHg and <110 mmHg). Timepoints:weekly—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Brazil, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)