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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-059-03
Enrollment
Unknown
Registered
2003-11-18
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

Diovan Type of group
Diovan 80 mg, Diovan 80 / 12.5 mg, diovan 160 / 12.5 mg will be administered consecutively for 4 weeks in each dose.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Outcome name:• Measure blood pressure • Review the concomitant medication. • Review the medical history • Ask about medications currently taken to determine if adverse events have occurred since the last visit • If the PAD is 10 mm Hg, the patient will receive the corresponding Level 1 medication for the following 4 weeks • 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 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. Timepoints:week 4

Secondary

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

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)