Trial Outcomes & Findings for Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus (NCT NCT00927394)
NCT ID: NCT00927394
Last Updated: 2012-12-06
Results Overview
The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1143 participants
Primary outcome timeframe
baseline, week 8
Results posted on
2012-12-06
Participant Flow
Participant milestones
| Measure |
Combination Therapy: Aliskiren + Valsartan
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
575
|
568
|
|
Overall Study
Cohort 1 (Randomized)
|
157
|
165
|
|
Overall Study
Cohort 2 (Randomized)
|
418
|
403
|
|
Overall Study
Combined Safety Set (Cohort 1 and 2)
|
574
|
565
|
|
Overall Study
Cohort 1: Full Analysis Set 1 (FAS 1)
|
157
|
164
|
|
Overall Study
Cohort 2: Full Analysis Set 2 (FAS 2)
|
417
|
398
|
|
Overall Study
FAS 2 :Ambulatory Blood Pressure Monitor
|
342
|
323
|
|
Overall Study
Combined Full Analysis Set (FAS 1+FAS 2)
|
574
|
562
|
|
Overall Study
COMPLETED
|
498
|
483
|
|
Overall Study
NOT COMPLETED
|
77
|
85
|
Reasons for withdrawal
| Measure |
Combination Therapy: Aliskiren + Valsartan
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
9
|
|
Overall Study
Unsatisfactory therapeutic effect
|
17
|
23
|
|
Overall Study
Withdrawal by Subject
|
20
|
24
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
|
Overall Study
Administrative Problem
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Protocol deviation
|
16
|
13
|
|
Overall Study
Randomized in error
|
0
|
1
|
Baseline Characteristics
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=574 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=565 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
Total
n=1139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.0 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 9.60 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
662 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=342 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=323 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8
|
-15.3 mmHg
Standard Deviation 14.62
|
-11.5 mmHg
Standard Deviation 14.75
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=562 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=553 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
|
-21.7 mmHg
Standard Deviation 18.70
|
-18.2 mmHg
Standard Deviation 18.06
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=342 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=323 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8
|
-9.2 mmHg
Standard Deviation 8.80
|
-6.7 mmHg
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.
The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=342 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=323 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8
|
-6.1 mmHg
Standard Deviation 8.58
|
-4.7 mmHg
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=562 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=553 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
|
-11.0 mmHg
Standard Deviation 10.58
|
-8.3 mmHg
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.
At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=562 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=553 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8
|
-10.8 mmHg
Standard Deviation 13.46
|
-9.9 mmHg
Standard Deviation 13.83
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.
Blood pressure control was defined as MSSBP/MSDBP \<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=514 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=498 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Percentage of Patients Achieving Blood Pressure Control
|
39.9 Percentage of patients
|
32.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Responders were defined as patients with MSSBP \<130 mmHg or a reduction from baseline in MSSBP of \>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=514 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=498 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Percentage of Responders
|
61.9 Percentage of patients
|
53.8 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=429 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=409 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Renin Activity (PRA) at Week 8
|
1.056 ng/mL/hr
Standard Deviation 4.966
|
0.879 ng/mL/hr
Standard Deviation 4.646
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=428 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=404 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
|
68.592 ng/L
Standard Deviation 209.544
|
124.721 ng/L
Standard Deviation 489.719
|
SECONDARY outcome
Timeframe: Baseline, week 8Population: Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=431 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=411 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Aldosterone at Week 8
|
-21.957 pmol/L
Standard Deviation 115.251
|
-22.562 pmol/L
Standard Deviation 123.343
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Safety Set - Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Outcome measures
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=574 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
|
Monotherapy: Valsartan
n=565 Participants
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Number of Patients With Adverse Events, Serious Adverse Events and Death
Adverse Events
|
202 Patients
|
182 Patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events and Death
Death
|
1 Patients
|
1 Patients
|
|
Number of Patients With Adverse Events, Serious Adverse Events and Death
Serious Adverse events
|
9 Patients
|
9 Patients
|
Adverse Events
Combination Therapy: Aliskiren + Valsartan
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Monotherapy: Valsartan
Serious events: 9 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=574 participants at risk
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
|
Monotherapy: Valsartan
n=565 participants at risk
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Cardiac disorders
Angina unstable
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Infections and infestations
Sweat gland infection
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Injury, poisoning and procedural complications
Injury
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Nervous system disorders
Paraesthesia
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.17%
1/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.00%
0/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
0.18%
1/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
Other adverse events
| Measure |
Combination Therapy: Aliskiren + Valsartan
n=574 participants at risk
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
|
Monotherapy: Valsartan
n=565 participants at risk
To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.9%
34/574
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
6.4%
36/565
Safety Set - Consists of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.
|
Additional Information
Study Directors
Novartis Pharmaceuticals
Phone: 862-778-8300
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER