Ignite Creation Date:
2024-05-05 @ 10:44 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01176032
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-08-02
Brief Title:
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
The ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling ALLMARK Study
Status:
COMPLETED
Status Verified Date:
2014-07
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:
ALLMARK
Brief Summary:
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular LV remodeling associated with LV hypertrophy LVH in hypertensive patients
Detailed Description:
Blood pressure was measured 10 weeks after starting treatment visit 3 All patients who did not achieve the required blood pressure 14090 mmHg after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP 14090 mmHg
The patients blood pressure was assessed at visit 4 week 18 and if it was still not at the required level 14090 mmHg the dose of amlodipine was increased to 10 mg
Blood pressure was again assessed at visit 5 week 26 and if the required values had not been reached 14090 mmHg a 125 mg dose of hydrochlorothiazide HCTZ was prescribed
The patients blood pressure was assessed at visit 4 week 18 and if it was still not at the required level 14090 mmHg the dose of amlodipine was increased to 10 mg
Blood pressure was again assessed at visit 5 week 26 and if the required values had not been reached 14090 mmHg a 125 mg dose of hydrochlorothiazide HCTZ was prescribed
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 |
|---|---|---|---|
| 2009-016735-36 | EUDRACT_NUMBER | None | None |