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

Tracking Information

First Received Date ^ICMJE

July 8, 2007

Last Updated Date

July 9, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Part 1 • Concentration of aliskiren, amlodipine and RAS biomarkers in body fluids and cells in obese patients with hypertension.

Change History

Complete list of historical versions of study NCT00498433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

• Effects of aliskiren and amlodipine on angiotensin II • Effects of aliskiren and amlodipine on biomarkers

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Abdominal Obesity

Intervention ^ICMJE

Drug: SPP100
Drug: Amlodipine

Study Arm (s)

Experimental: aliskiren
Intervention: Drug: SPP100
Active Comparator: amlodipine
Intervention: Drug: Amlodipine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00498433

Other Study ID Numbers ^ICMJE

CSPP100A2238

Has Data Monitoring Committee

Yes

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Novartis

Investigative site

Information Provided By

Novartis

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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