Trial Outcomes & Findings for Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects (NCT NCT01349114)

Results Overview

Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Aliskiren aliskiren 300 mg daily	Sugar Pill/Placebo Sugar pill/placebo arm
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aliskiren n=10 Participants aliskiren 300 mg daily	Placebo n=11 Participants Sugar pill/placebo	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 11 • n=5 Participants	63.4 years STANDARD_DEVIATION 8.3 • n=7 Participants	60.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Outcome measures

Outcome measures
Measure	Aliskiren n=10 Participants aliskiren 300 mg daily	Placebo n=11 Participants Sugar pill/ placebo
Change in Flow-mediated Dilation	7.9 percentage of flow-mediated dilation Standard Deviation 2.5	4.1 percentage of flow-mediated dilation Standard Deviation 1.3

SECONDARY outcome

Timeframe: 3 months after start of study

Population: Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.

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)

Outcome measures

Outcome measures
Measure	Aliskiren n=10 Participants aliskiren 300 mg daily	Placebo n=11 Participants Sugar pill/ placebo
Mean Central Aortic Pressure at 3 Months aortic systolic blood pressure	113.4 mm Hg Standard Deviation 12.0	122.3 mm Hg Standard Deviation 9.6
Mean Central Aortic Pressure at 3 Months aortic diastolic blood pressure	78.9 mm Hg Standard Deviation 8.9	83.3 mm Hg Standard Deviation 9.9
Mean Central Aortic Pressure at 3 Months aortic pressure	7.1 mm Hg Standard Deviation 7.2	10.3 mm Hg Standard Deviation 5.7

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David A. Calhoun, MD

University of Alabama at Birmingham

Phone: 205-934-4633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place