Trial Outcomes & Findings for Aliskiren Effect on Aortic Plaque Progression (NCT NCT01417104)
NCT ID: NCT01417104
Last Updated: 2017-05-11
Results Overview
All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements. An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated.
TERMINATED
PHASE2/PHASE3
71 participants
Baseline and end of treatment ( 17 to 36 weeks)
2017-05-11
Participant Flow
Participants recruited from The Ohio State Medical Center and Columbus surrounding area between April 2009 to December 2011.
187 participants screened; 116 did not meet inclusion criteria or meet exclusion criteria; 71 randomized.
Participant milestones
| Measure |
Aliskiren
Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
|
Overall Study
COMPLETED
|
28
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Aliskiren
Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Failure to make contact
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Aliskiren Effect on Aortic Plaque Progression
Baseline characteristics by cohort
| Measure |
Aliskiren
n=34 Participants
Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
n=37 Participants
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
Total
n=71 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
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
64.18 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
37 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment ( 17 to 36 weeks)Population: 3 MRI data sets were not analyzable ( low quality images), and 23 post-treatment MRI not obtained ( \<17 weeks on drug when trial terminated owing to ALTITUDE results)
All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements. An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated.
Outcome measures
| Measure |
Aliskiren
n=18 Participants
Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
n=19 Participants
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment
|
5.31 mm3
Standard Deviation 6.57
|
0.15 mm3
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline and end of treatment ( 17 to 36 weeks)Population: 3 MRI not analyzable, 23 final MRI not obtained due to trial termination
Using an approach similar to intravascular atheroma volume calculations, percentage wall volume (PWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated. and a difference between baseline and end of treatment was calculated.
Outcome measures
| Measure |
Aliskiren
n=18 Participants
Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
n=19 Participants
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment
|
3.37 Percentage of the Outer Wall Volume
Standard Deviation 2.96
|
0.97 Percentage of the Outer Wall Volume
Standard Deviation 2.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to end of treatment ( up to 36 weeks)Population: Intent to treat analysis including only participants who had at least one post-baseline assesment
Difference between end of treatment and baseline in resting diastolic blood pressure
Outcome measures
| Measure |
Aliskiren
n=28 Participants
Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
n=35 Participants
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Change From Baseline in Resting Diastolic Blood Pressure
|
-3.88 mm Hg
Interval -9.23 to 1.47
|
-2.32 mm Hg
Interval -6.39 to 1.7
|
Adverse Events
Aliskiren
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aliskiren
n=34 participants at risk
Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
|
Placebo
n=37 participants at risk
Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • Number of events 1 • up to 36 weeks
|
0.00%
0/37 • up to 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place