Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00993109
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2009-10-09
Brief Title:
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
RandomizedOpen-labelParallel Design Comparator Study of Effect of Nifedipine GITSOROS Adalat 30 mg in Combination With Valsartan Diovan 80 mg Compared to Valsartan Diovan 160 mg Monotherapy in Patients Whose Blood Pressure is Not Well Controlled by Valsartan 80 mg Alone
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This will be a multi-center prospective randomized open-label parallel design two arm comparator trial In the proposed study the investigators will compare low-dose combination therapy of Nifedipine GITSOROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertensionThe study consists of a screening visit followed by randomization and administration of either Nifedipine GITSOROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatmentThe primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ADVISE | OTHER | Company Internal | None |