Trial Outcomes & Findings for Direct Renin Inhibition Effects on Atherosclerotic Biomarkers (NCT NCT00818779)

Results Overview

Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

6 weeks (change from baseline)

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Aliskiren Aliskiren 150-300 mg once daily	Amlodipine 5-10 mg amlodipine once daily
Overall Study STARTED	22	16
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Aliskiren Aliskiren 150-300 mg once daily	Amlodipine 5-10 mg amlodipine once daily
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	4	1

Baseline Characteristics

Direct Renin Inhibition Effects on Atherosclerotic Biomarkers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aliskiren n=22 Participants Aliskiren 150-300 mg once daily	Amlodipine n=16 Participants 5-10 mg amlodipine once daily	Total n=38 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	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 16 • n=7 Participants	65 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	16 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks (change from baseline)

Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.

Outcome measures

Outcome measures
Measure	Aliskiren n=16 Participants Aliskiren 150-300 mg once daily	Amlodipine n=15 Participants 5-10 mg amlodipine once daily
Plasminogen Activator Inhibitor 1	0.65 ng/ml Interval -7.33 to 8.62	3.82 ng/ml Interval -5.16 to 12.81

SECONDARY outcome

Timeframe: 6 week (change from baseline)

Surrogate biomarker cardiovascular risk

Outcome measures

Outcome measures
Measure	Aliskiren n=16 Participants Aliskiren 150-300 mg once daily	Amlodipine n=15 Participants 5-10 mg amlodipine once daily
Serum Level of Vascular Cell Adhesion Molecule	-2.4 ng/ml Interval -41.1 to 36.3	-45.9 ng/ml Interval -112.8 to 21.0

SECONDARY outcome

Timeframe: 6 week (change from baseline)

Surrogate biomarker of cardiovascular risk

Outcome measures

Outcome measures
Measure	Aliskiren n=16 Participants Aliskiren 150-300 mg once daily	Amlodipine n=15 Participants 5-10 mg amlodipine once daily
Serum Level of Intracellular Cell Adhesion Molecule	-4.9 ng/ml Interval -17.2 to 7.4	-10.3 ng/ml Interval -31.2 to 10.6

SECONDARY outcome

Timeframe: 6 week (change from baseline)

Surrogate biomarker of cardiovascular risk

Outcome measures

Outcome measures
Measure	Aliskiren n=16 Participants Aliskiren 150-300 mg once daily	Amlodipine n=15 Participants 5-10 mg amlodipine once daily
Serum Level of C-reactive Protein	0.0397 mg/l Interval -0.231 to 0.3104	0.1032 mg/l Interval -0.1974 to 0.4038

SECONDARY outcome

Timeframe: 6 week (change from baseline)

Surrogate biomarker of cardiovascular risk

Outcome measures

Outcome measures
Measure	Aliskiren n=16 Participants Aliskiren 150-300 mg once daily	Amlodipine n=15 Participants 5-10 mg amlodipine once daily
Serum Level of Nitric Oxide	2.66 mmmol/l Interval -7.45 to 12.76	7.49 mmmol/l Interval -1.43 to 16.41

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amlodipine

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

Gary Meyerrose

Texas Tech University Health Sciences Center School of Medicine

Phone: 806-743-3150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place