Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498433
Status:
TERMINATED
Last Update Posted:
2014-09-10
First Post:
2007-07-08
Brief Title:
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System RAS and LipidCarbohydrate Metabolism in Obese Patients With Hypertension
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Part 1 An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System RAS in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity Part 2 A Randomized Double Blind 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and LipidCarbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination resulted from interim analysis of the ALTITUDE trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part 1 determined aliskiren amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle aliskiren and angiotensin II concentrations and renin activity and concentration in fat and skeletal muscle tissues biopsies aliskiren amlodipine and angiotensin II concentrations and renin activity and concentration in plasma
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system RAAS activity and lipidcarbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system RAAS activity and lipidcarbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine
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