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

NCT ID: NCT00498433

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aliskiren

Part 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d..

Part 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks.

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

300 mg tablet once daily

Placebo of Aliskiren

Intervention Type: DRUG

Matching placebo of aliskiren 300 mg tablet

Placebo of amlodipine

Intervention Type: DRUG

Matching placebo of amlodipine 5 mg capsule

Amlodipine

Part 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.

Part 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

5 mg capsule once daily

Placebo of Aliskiren

Intervention Type: DRUG

Matching placebo of aliskiren 300 mg tablet

Interventions

Aliskiren

300 mg tablet once daily

Intervention Type: DRUG

Amlodipine

5 mg capsule once daily

Intervention Type: DRUG

Placebo of Aliskiren

Matching placebo of aliskiren 300 mg tablet

Intervention Type: DRUG

Placebo of amlodipine

Matching placebo of amlodipine 5 mg capsule

Intervention Type: DRUG

Other Intervention Names

SPP100

Eligibility Criteria

Inclusion Criteria

PART 1:

• Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
• For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg
• Pulse rate 40 - 90 bpm

PART 2:

• Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
• Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:

1. Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and < 160/100 mmHg at baseline

2. Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg and < 160/100 mmHg at screening and baseline.

Exclusion Criteria

PART 1

• Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification
• Current treatment with three or more antihypertensive drugs.

PART 2

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative site

Locations

Novartis Investigative Site

Buch, , Germany

Novartis Investigative Site

Hanover, , Germany

Countries

Germany

Other Identifiers

CSPP100A2238

Identifier Type: -

Identifier Source: org_study_id