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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 4

Conditions: Hypertension; Diabetes; Pre-hypertension

Treatments: Drug: Placebo/sugar pill; Drug: aliskiren 300 mg once daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01349114

F110124007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

aliskiren 300 mg once daily for 12 weeks

Active Comparator group

Description:

aliskiren 300 mg daily

Treatment:

Drug: aliskiren 300 mg once daily

Sugar pill/ placebo

Placebo Comparator group

Description:

Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo

Treatment:

Drug: Placebo/sugar pill