Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: valsartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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). |
- Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
- 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
| Enrollment: | 551 |
| Study Start Date: | March 2004 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00333489 History of Changes |
| Other Study ID Numbers: | CVAL489ABR02 |
| Study First Received: | June 1, 2006 |
| Last Updated: | November 7, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Novartis:
|
valsartan amlodipine hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Amlodipine, valsartan drug combination Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013