drugset / Trial / NCT00498433

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

NCT00498433

Phase 2 Terminated 46 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-06
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 300 mg
Comparator Amlodipine Other / unclassified 5 mg