MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY, WITH ACTIVE CONTROL, IN PARALLEL GROUPS, TO EVALUATE THE EFFICACY AND SAFETY OF VALSARTAN 320 MG COMPARED WITH VALSARTAN 160 MG IN HYPERTENSION PATIENTS

Phase 1

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-060-03
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-11-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Women and men between 18 and 80 years of age inclusive.
2. To those who in the recruitment (visit 2) have been diagnosed with mild to moderate hypertension, with a MSDBP> 95 and <109 mmHg for untreated patients. Patients with previous treatment should have an MSDBP <109 mmHg at visit 1 and an MSDBP> 95 and <109 mmHg at visit 2.
3. That they have given their written informed consent before any study procedure is performed.
4. Able to communicate and meet all the requirements of the study.

Exclusion Criteria

1. Severe hypertension (grade 3 of the WHO classification,> 110 mmHg diastolic and / or> 180 mmHg systolic).
2. Malignant hypertension
3. Impossibility to discontinue all previous antihypertensive medication safely for a period of 2 weeks, as required by the protocol.
4. Known background of proteinuria (more than 0.3 grams per day)
5. Women patients who have not been postmenopausal 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 is not allowed.
6. Degree m or IV known in the classification of hypertensive retinopathy of Keith-Wagener.
7. History of hypertensive encephalopathy or stroke at any time before Visit 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The primary efficacy evaluation will consist of the valuation, at the end of the treatment period, of the change in the MSDBP in the valley from the baseline value in the population as a whole.<br>Measure:Blood pressure lowering effects of the 4-week treatment with a once-daily regimen of Valsartan 320 mg, compared to Valsartan 160 mg, in patients with uncomplicated diastolic essential hypertension (MSDBP> 95 nun Hg and <109 mm Hg).<br>Timepoints:Week 4<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The secondary efficacy evaluation will consist of the valuation, at the end of the treatment period, of the change in the MSDBP in the valley from the baseline in Stratum 2.<br>Measure:The blood pressure lowering effects of the 4-week treatment with a once-a-day regimen of Valsartan 320 mg, compared to Valsartan 160 mg, in non-responder patients at the 160 mg dose as specified in the ICH Regulations (MSDBP) > = 90 mmHg) in the randomization.<br>Timepoints:Week 4<br>