EVALUATION OF THE EFFICACY AND TOLERANCE OF VALSARTAN AND VALSARTAN / HYDROCHLOROTHIAZIDE IN LATIN AMERICAN HYPERTENSIONS

Not Applicable

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

• Registration Number: PER-059-03
• 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: 2003-11-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients who give their informed consent in writing
2. Men or women over 18 years of age.
3. Patients who have been diagnosed for the first time mild to moderate hypertension according to the following criteria: mild arterial hypertension defined as SBP between 140 and 159 mmHg and / or DBP between 90 and 99 mmHg. Moderate arterial hypertension defined as SBP between 160 and 179 and / or DBP between 100 and 109 mmHg.
4. Patients who can not tolerate treatment with other antihypertensive agents and may, at the discretion of the attending physician, be changed to Angiotensin Receptor Antagonists.
5. Patients taking other antihypertensive drugs but not controlled (SBP between 140 and 179 mmHg and / or DBP between 90 and 109 mmHg).

Exclusion Criteria

1. Pregnant or lactating women
2. Women of childbearing age who are not using a valid contraceptive method
3. Malignant hypertension
4. Hypertension in treatment with more than one medication, including presentations with a fixed combination of antihypertensive drugs.
5. Secondary hypertension (Aortic Coarctation, hyperaldosteronism, renal artery stenosis, pheochromocytoma)
6. Clinically significant liver disease SGOT (AST), SGPT (ALT)> twice the normal upper limit, biliary cirrhosis or obstructive cholestasis
7. Renal insufficiency with creatinine> 1.5 times the normal upper limit, history of dialysis or nephrotic syndrome.
8. Allergy or a hypersensitivity to angiotensin II receptor antagonists or thiazide diuretics.
9. Patients who do not wish to comply with the specifications of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:• Measure blood pressure<br>• Review the concomitant medication.<br>• Review the medical history<br>• Ask about medications currently taken to determine if adverse events have occurred since the last visit<br>• If the PAD is <90 mm Hg or has experienced a decrease> 10 mm Hg, the patient will receive the corresponding Level 1 medication for the following 4 weeks<br>• If the DBP is> 90 mm Hg or has not experienced a decrease> 10 mm Hg, the patient will receive the corresponding Level 2 medication for the next 4 weeks<br>Measure:Diovan® 80 mg and the association Diovan® HCT (Valsartan 80 mg / Hydrochlorothiazide 12.5 mg and Valsartan 160 mg / Hydrochlorothiazide 12.5 mg) are effective and well tolerated treatments in patients with mild to moderate hypertension.<br>Timepoints:week 4<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:not contemplated<br><br>Measure:not contemplated<br><br>Timepoints:not contemplated<br>