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

NCT00498433 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-09-10

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis · Investigative site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00498433 on ClinicalTrials.gov