Trial Outcomes & Findings for Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension (NCT NCT00705575)
NCT ID: NCT00705575
Last Updated: 2011-05-30
Results Overview
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
COMPLETED
PHASE3
688 participants
Baseline to end of study (Week 12)
2011-05-30
Participant Flow
Participant milestones
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
349
|
339
|
|
Overall Study
COMPLETED
|
326
|
293
|
|
Overall Study
NOT COMPLETED
|
23
|
46
|
Reasons for withdrawal
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
3
|
|
Overall Study
Abnormal test procedure result(s)
|
2
|
12
|
|
Overall Study
Adverse Event
|
11
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
Baseline Characteristics
Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=349 Participants
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=339 Participants
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
Total
n=688 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.4 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.73 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 12)Population: Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Outcome measures
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=346 Participants
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=335 Participants
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
|
-30.01 mm Hg
Standard Error 1.053
|
-20.29 mm Hg
Standard Error 1.067
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Outcome measures
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=346 Participants
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=335 Participants
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
|
-30.09 mm Hg
Standard Error 1.079
|
-20.75 mm Hg
Standard Error 1.094
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Outcome measures
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=346 Participants
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=335 Participants
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
Baseline to Week 8
|
-13.69 mm Hg
Standard Error 0.599
|
-7.99 mm Hg
Standard Error 0.607
|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
Baseline to Week 12
|
-12.64 mm Hg
Standard Error 0.590
|
-8.18 mm Hg
Standard Error 0.598
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Outcome measures
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=346 Participants
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=335 Participants
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12
Baseline to Week 8
|
53.5 Percentage
|
30.4 Percentage
|
|
Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12
Baseline to Week 12
|
54.6 Percentage
|
32.2 Percentage
|
Adverse Events
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
Aliskiren (300 mg)
Serious adverse events
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=349 participants at risk
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=339 participants at risk
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/349
|
0.29%
1/339
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.29%
1/349
|
0.00%
0/339
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/349
|
0.29%
1/339
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/349
|
0.29%
1/339
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.29%
1/349
|
0.00%
0/339
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/349
|
0.59%
2/339
|
Other adverse events
| Measure |
Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)
n=349 participants at risk
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
|
Aliskiren (300 mg)
n=339 participants at risk
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.4%
19/349
|
2.9%
10/339
|
|
Nervous system disorders
Headache
|
4.0%
14/349
|
8.6%
29/339
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER