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

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ClinicalTrials.gov Identifier: NCT01067326
Recruitment Status : Terminated (Novartis ended all studies regarding Aliskiren.)
First Posted : February 11, 2010
Results First Posted : February 13, 2013
Last Update Posted : February 13, 2013
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Novartis
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Endothelial Dysfunction
Interventions Drug: Aliskiren
Drug: Placebo
Enrollment 22
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description 150 mg Aliskiren once daily for a period of 4 months. 1 pill per day by mouth for 4 months.
Period Title: Overall Study
Started 14 8
Completed 12 5
Not Completed 2 3
Reason Not Completed
Adverse Event             0             2
Withdrawal by Subject             1             0
Early Study Termination             1             1
Arm/Group Title Aliskiren Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 12 5 17
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 5 participants 17 participants
43.1  (17.5) 51.0  (20.7) 45.4  (18.2)
[1]
Measure Description: Not all baseline data were available from "started" subjects, therefore only baseline data for "completed" subjects is presented.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 5 participants 17 participants
Female
7
  58.3%
1
  20.0%
8
  47.1%
Male
5
  41.7%
4
  80.0%
9
  52.9%
[1]
Measure Description: Not all baseline data were available from "started" subjects, therefore baseline data for "completed" subjects is presented.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 5 participants 17 participants
12 5 17
[1]
Measure Description: Not all baseline data were available from "started" subjects, therefore baseline data for "completed" subjects is presented.
1.Primary Outcome
Title Endothelial Progenitor Cells (EPC)
Hide Description Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.
Time Frame Baseline, 4 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
150 mg Aliskiren once daily for a period of 4 months.
1 pill per day by mouth for 4 months.
Overall Number of Participants Analyzed 12 5
Median (Inter-Quartile Range)
Unit of Measure: counts per 100,000 gated events
Baseline
24
(1 to 35)
9
(3 to 19)
4 Months
3
(0 to 15)
8
(2 to 11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren
Comments Change in EPCs from baseline to 4 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Reactive Hyperemia Index (RHI)
Hide Description 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.
Time Frame Baseline, 4 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
150 mg Aliskiren once daily for a period of 4 months.
1 pill per day by mouth for 4 months.
Overall Number of Participants Analyzed 12 5
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline
1.93
(1.66 to 1.99)
1.81
(1.63 to 2.05)
4 Months
1.73
(1.56 to 2.01)
1.68
(1.41 to 2.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren, Placebo
Comments P-value for intergroup comparison of change from baseline to month 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, 4 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
150 mg Aliskiren once daily for a period of 4 months.
1 pill per day by mouth for 4 months.
Overall Number of Participants Analyzed 12 5
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 124.6  (12.2) 118.8  (18.1)
4 Months 112.3  (12.4) 116.2  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren
Comments Difference in systolic blood pressure from baseline to 4 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, 4 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description:
150 mg Aliskiren once daily for a period of 4 months.
1 pill per day by mouth for 4 months.
Overall Number of Participants Analyzed 12 5
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 77.8  (9.9) 68.6  (10.2)
4 Months 70.0  (11.6) 67.6  (9.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aliskiren
Comments Difference in diastolic blood pressure from baseline to 4 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aliskiren Placebo
Hide Arm/Group Description 150 mg Aliskiren once daily for a period of 4 months. 1 pill per day by mouth for 4 months.
All-Cause Mortality
Aliskiren Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aliskiren Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      2/5 (40.00%)    
Gastrointestinal disorders     
Irritated bowel   0/12 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
Rash   0/12 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
The study was terminated early due to safety concerns from the ALTITUDE trial; there was an unexpected increase in adverse events (non-fatal stroke, renal complications, hyperkalemia and hypotension). Novartis ended all studies regarding Aliskiren.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Amir Lerman
Organization: Mayo Clinic
Phone: 507-255-4152
Responsible Party: Amir Lerman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01067326     History of Changes
Other Study ID Numbers: 09-007617
R01AG031750 ( U.S. NIH Grant/Contract )
R01HL092954 ( U.S. NIH Grant/Contract )
First Submitted: February 8, 2010
First Posted: February 11, 2010
Results First Submitted: January 9, 2013
Results First Posted: February 13, 2013
Last Update Posted: February 13, 2013