Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Hypertension Clinical Trial

Official title:

Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01349114
• Other study ID #: F110124007
• Status: Terminated
• Phase: Phase 4
• First received: May 4, 2011
• Last updated: July 15, 2014
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Description:

Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• prehypertension or Stage 1 hypertension

Exclusion Criteria:

• Type 1 diabetes

• Stage 2 hypertension

• CKD

• recent MI, revascularization, CVA or TIA

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

Drug:
• aliskiren 300 mg once daily
aliskiren 300 mg daily
• Placebo/sugar pill
Sugar pill/placebo

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Flow-mediated Dilation	Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion	Baseline to 3 months	No
Secondary	Mean Central Aortic Pressure at 3 Months	Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)	3 months after start of study	No