Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333489
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2006-06-01
Brief Title:
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
Sponsor:
Novartis
Organization:
Novartis
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate efficacy safety and tolerability of the valsartanamlodipine 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 andor MSSBP 180 mmHg during the open-label treatment phase will be discontinued from the study
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 andor MSSBP 180 mmHg during the open-label treatment phase will be discontinued from the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None