NCT00498433

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension

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 Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.

Conditions

• Hypertension
• Abdominal Obesity

Interventions

Type	Name	Description
DRUG	Aliskiren	300 mg tablet once daily
DRUG	Amlodipine	5 mg capsule once daily
DRUG	Placebo of Aliskiren	Matching placebo of aliskiren 300 mg tablet
DRUG	Placebo of amlodipine	Matching placebo of amlodipine 5 mg capsule

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2007-07-10
• Last updated: 2014-09-10
• Results posted: 2013-10-24

Locations

2 sites across 1 country: Germany