Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333489

Enrollment

551

Registered

2006-06-05

Start date

2004-03-31

Completion date

2005-04-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

valsartan, amlodipine, hypertension

Brief summary

The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone. Patients should have mild to moderate essential hypertension \[grades 1 and 2 of WHO classification (8)\]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure. For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP \> 110 mmHg and/or MSSBP \> 180 mmHg) during the open-label treatment phase will be discontinued from the study.

Interventions

DRUGvalsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Inclusion criteria

Incl- Patients with mild to moderate essential hypertension (grade 1 and 2 of WHO classification). \- Patients with essential diastolic hypertension measured by a standard aneroid or mercury column sphygmomanometer showing MSDBP \> 95 mmHg and \< 110 mmHg and MSSBP \<180 mmHg.

Exclusion criteria

* Severe hypertension (grade 3 of WHO classification: DBP \>= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension. * Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol. * Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks	—

Secondary

Measure	Time frame
Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks	—
Adverse events after 8 weeks	—
Change from baseline in standing blood pressure and heart rate after 8 weeks	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026