CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Aliskiren +3 moredrug
Likely dose
Aliskiren 300 mg orally once daily or Amlodipine 5 mg orally once dailyAI-extracted
Key inclusion· 5
  • ✓Age 18-55 years
  • ✓Hypertension with sitting diastolic BP ≥80 mmHg or systolic BP ≥130 mmHg at screening
  • ✓Metabolic syndrome by ATP III criteria plus impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)
  • ✓Evidence of insulin resistance: abnormal euglycemic clamp (glucose infusion rate ≤4.2 mg/kg/min) and/or endothelial dysfunction: abnormal PET (myocardial blood flow ≤35%)
Key exclusion· 8
  • ✕Smokers or recent tobacco use
  • ✕Recent cardiovascular events or procedures (MI, angina, stroke, TIA, cardiac revascularization/angioplasty in past 12 months)
  • ✕Congestive heart failure or LVEF <40%
  • ✕Supine BP ≥160 mmHg systolic or ≥110 mmHg diastolic

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00417170
NCT00417170Phase 2Completed
CompareCT.gov

A Double-blind, Double Dummy, Randomized Parallel Design Trial to Study the Effects of 12 Weeks of Treatment With 300mg Aliskiren vs. 5mg Amlodipine on Insulin Resistance and Endothelial Dysfunction in Hypertensive Patients With Metabolic Syndrome

Novartis Pharmaceuticals·interventional·Posted Dec 29, 2006·Updated Sep 26, 2011

In Brief

A Phase 2 clinical trial evaluating Aliskiren, Amlodipine, and 2 other interventions for High Blood Pressure and 3 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh Blood Pressure, Metabolic Syndrome, Insulin Resistance, Endothelial Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 29, 2006
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago

Interventions

Aliskirendrug

Aliskiren 300 mg tablets taken orally once daily

Amlodipinedrug

Amlodipine 5 mg capsule taken orally once daily

Placebo Aliskirendrug

Placebo Aliskiren taken orally once daily.

Placebo Amlodipinedrug

Placebo Amlodipine taken orally once daily