Trial Outcomes & Findings for The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis (NCT NCT01067326)

NCT ID: NCT01067326

Last Updated: 2013-02-13

Results Overview

Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline, 4 Months
• Results posted on: 2013-02-13

Participant Flow

Subjects were recruited from the Division of Cardiology at the Mayo Clinic in Rochester, Minnesota. 22 subjects were randomized to the study, 2 subjects were affected by the early study termination and thus have no follow-up data.

Participant milestones

Measure	Aliskiren 150 mg Aliskiren once daily for a period of 4 months.	Placebo 1 pill per day by mouth for 4 months.
Overall Study STARTED	14	8
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Aliskiren 150 mg Aliskiren once daily for a period of 4 months.	Placebo 1 pill per day by mouth for 4 months.
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Early Study Termination	1	1

Baseline Characteristics

The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

Baseline characteristics by cohort

Measure	Aliskiren n=12 Participants 150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from "started" subjects, therefore only baseline data for "completed" subjects is presented.	Placebo n=5 Participants 1 pill per day by mouth for 4 months. Not all baseline data were available from "started" subjects, therefore only baseline data for "completed" subjects is presented.	Total n=17 Participants Total of all reporting groups
Sex: Female, Male Male	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	5 participants n=4 Participants	17 participants n=27 Participants
Age Continuous	43.1 years STANDARD_DEVIATION 17.5 • n=93 Participants	51.0 years STANDARD_DEVIATION 20.7 • n=4 Participants	45.4 years STANDARD_DEVIATION 18.2 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	1 Participants n=4 Participants	8 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 4 Months

Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.

Outcome measures

Measure	Aliskiren n=12 Participants 150 mg Aliskiren once daily for a period of 4 months.	Placebo n=5 Participants 1 pill per day by mouth for 4 months.
Endothelial Progenitor Cells (EPC) Baseline	24 counts per 100,000 gated events Interval 1.0 to 35.0	9 counts per 100,000 gated events Interval 3.0 to 19.0
Endothelial Progenitor Cells (EPC) 4 Months	3 counts per 100,000 gated events Interval 0.0 to 15.0	8 counts per 100,000 gated events Interval 2.0 to 11.0

PRIMARY outcome

Timeframe: Baseline, 4 Months

RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

Outcome measures

Measure	Aliskiren n=12 Participants 150 mg Aliskiren once daily for a period of 4 months.	Placebo n=5 Participants 1 pill per day by mouth for 4 months.
Reactive Hyperemia Index (RHI) Baseline	1.93 units on a scale Interval 1.66 to 1.99	1.81 units on a scale Interval 1.63 to 2.05
Reactive Hyperemia Index (RHI) 4 Months	1.73 units on a scale Interval 1.56 to 2.01	1.68 units on a scale Interval 1.41 to 2.19

SECONDARY outcome

Timeframe: Baseline, 4 Months

Outcome measures

Measure	Aliskiren n=12 Participants 150 mg Aliskiren once daily for a period of 4 months.	Placebo n=5 Participants 1 pill per day by mouth for 4 months.
Systolic Blood Pressure Baseline	124.6 mm Hg Standard Deviation 12.2	118.8 mm Hg Standard Deviation 18.1
Systolic Blood Pressure 4 Months	112.3 mm Hg Standard Deviation 12.4	116.2 mm Hg Standard Deviation 11.9

SECONDARY outcome

Timeframe: Baseline, 4 Months

Outcome measures

Measure	Aliskiren n=12 Participants 150 mg Aliskiren once daily for a period of 4 months.	Placebo n=5 Participants 1 pill per day by mouth for 4 months.
Diastolic Blood Pressure Baseline	77.8 mm Hg Standard Deviation 9.9	68.6 mm Hg Standard Deviation 10.2
Diastolic Blood Pressure 4 Months	70.0 mm Hg Standard Deviation 11.6	67.6 mm Hg Standard Deviation 9.8

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aliskiren n=12 participants at risk 150 mg Aliskiren once daily for a period of 4 months.	Placebo n=5 participants at risk 1 pill per day by mouth for 4 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • A study coordinator contacted the subjects by phone once weekly for the first month of the study and every month thereafter for the remainder of the study (4 months) to insure the safety of the subjects.	20.0% 1/5 • Number of events 1 • A study coordinator contacted the subjects by phone once weekly for the first month of the study and every month thereafter for the remainder of the study (4 months) to insure the safety of the subjects.
Gastrointestinal disorders Irritated bowel	0.00% 0/12 • A study coordinator contacted the subjects by phone once weekly for the first month of the study and every month thereafter for the remainder of the study (4 months) to insure the safety of the subjects.	20.0% 1/5 • Number of events 1 • A study coordinator contacted the subjects by phone once weekly for the first month of the study and every month thereafter for the remainder of the study (4 months) to insure the safety of the subjects.

Additional Information

Dr. Amir Lerman

Mayo Clinic

Phone: 507-255-4152

Email: lerman.amir@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place