Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Abdominal Obesity
Intervention: Aliskiren (Drug); Amlodipine (Drug); Placebo of Aliskiren (Drug); Placebo of amlodipine (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Principal Investigator, Affiliation: Investigative site
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment PeriodPart 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period Part 1: Renin Activity From Plasma During Aliskiren Treatment Period Part 1: Renin Activity From Plasma During Amlodipine Treatment Period Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period
Secondary outcome: Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)Part 2: Change From Baseline in Official Blood Pressure Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies) Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Other protocol-defined inclusion/exclusion criteria applied
Locations and Contacts
Novartis Investigative Site, Berlin-Buch 13125, Germany
Novartis Investigative Site, Hannover 30159, Germany
Additional Information
Starting date: June 2007
Last updated: September 9, 2014
|