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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00498433
First received: July 8, 2007
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

Part 1 investigated aliskiren, amlodipine and angiotensin II levels in interstitial fluid of fat and skeletal muscle; aliskiren concentration, angiotensin II levels, and renin activity and concentration in fat and skeletal muscle tissues; aliskiren and amlodipine concentrations, angiotensin II levels, and renin activity and concentrations in plasma.

Part 2 investigates 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.


Condition Intervention Phase
Hypertension
Abdominal Obesity
 Drug: SPP100
Drug: Amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Part 1: Concentration of aliskiren, amlodipine and RAS biomarkers in body fluids and solid tissue in obese patients with hypertension. [ Time Frame: 2 weeks, 6 weeks and 14 weeks ] [ Designated as safety issue: No ]
  • Part 2: Concentration of plasma biomarkers; effects of aliskiren and amlodipine in interstitial fluid of subcutaneous fat and skeletal muscle. [ Time Frame: Day 14 and Day 98 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequently sampled intravenous glucose tolerance test with insulin bolus [ Time Frame: Day 14 and Day 98 ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Day 14 and Day 98 ] [ Designated as safety issue: Yes ]
  • Concentration of aliskiren and amlodipine in plasma [ Time Frame: Day 14 and Day 98 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aliskiren Drug: SPP100
Active Comparator: amlodipine Drug: Amlodipine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male and female patients 18 to 65 years of age included, with a diagnosis of hypertension and with abdominal obesity (elevated waist circumference, ≥ 102 cm in men and ≥ 88 cm in women)

Systolic and diastolic blood pressure and pulse rate will be assessed after the patient has rested for at least five (5) minutes. Vital signs should be within the following ranges:

Patients with history of treated hypertension: msSBP/msDBP < 160/100 mmHg and ≥ 135/85 mmHg at baseline Patients who are newly diagnosed (untreated): msSBP/msDBP ≥ 135/85 mmHg and a msSBP/msDBP < 160/100 mmHg at screening, predose, and baseline,

Exclusion criteria:

Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg). Current treatment with three or more antihypertensive treatments.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498433

Locations
Germany
Novartis Investigative Site
Hannover, Germany
Novartis Investigative Site
Nuernberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00498433     History of Changes
Other Study ID Numbers: CSPP100A2238
Study First Received: July 8, 2007
Last Updated: July 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Aliskiren
Renin-Angiotensin System (RAS)
Hypertension
Abdominal obesity

Additional relevant MeSH terms:
Hypertension
Obesity
Obesity, Abdominal
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013