Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523744
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2007-08-30
Brief Title:
Efficacy and Safety of Valsartan and Amlodipine HCTZ in Adults With Moderate Inadequately Controlled Hypertension
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker Olmesartan 20 mg Plus Amlodipine 10 mg
Status:
COMPLETED
Status Verified Date:
2020-07
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:
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate inadequately controlled hypertension There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy ie hydrochlorothiazide amlodipinevalsartan
Detailed Description:
Title of study extension An open-label multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 125 mg plus amlodipine 10 mgvalsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mgvalsartan 160 mg
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