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).
1 other identifier
interventional
551
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Mar 2004
Shorter than P25 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 5, 2006
CompletedNovember 8, 2011
June 1, 2006
1.1 years
June 1, 2006
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
Basel, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 5, 2006
Study Start
March 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
November 8, 2011
Record last verified: 2006-06