Trial Outcomes & Findings for Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension (NCT NCT00765674)
NCT ID: NCT00765674
Last Updated: 2011-05-09
Results Overview
Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1191 participants
Primary outcome timeframe
Baseline to end of study (Week 8)
Results posted on
2011-05-09
Participant Flow
In the single-blind period, 1909 patients were enrolled, 1189 completed, and 720 discontinued. Of the 1191 randomized patients, 2 patients were randomized by error and discontinued in the single-blind period without taking double-blind medication.
Participant milestones
| Measure |
Aliskiren / Amlodipine
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
287
|
298
|
296
|
310
|
|
Overall Study
COMPLETED
|
266
|
276
|
279
|
285
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
17
|
25
|
Reasons for withdrawal
| Measure |
Aliskiren / Amlodipine
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
8
|
11
|
|
Overall Study
Abnormal Laboratory Value(s)
|
0
|
0
|
1
|
0
|
|
Overall Study
Abnormal Test Procedure Result(s)
|
1
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
1
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
2
|
1
|
|
Overall Study
Randomized in Error - No Study Drug
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren / Amlodipine
n=287 Participants
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=298 Participants
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=296 Participants
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=310 Participants
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Total
n=1191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
54.4 years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 10.86 • n=21 Participants
|
|
Age, Customized
< 65 years
|
237 participants
n=5 Participants
|
242 participants
n=7 Participants
|
233 participants
n=5 Participants
|
251 participants
n=4 Participants
|
963 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
50 participants
n=5 Participants
|
56 participants
n=7 Participants
|
63 participants
n=5 Participants
|
59 participants
n=4 Participants
|
228 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
471 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
720 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Outcome measures
| Measure |
Aliskiren / Amlodipine
n=282 Participants
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=296 Participants
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=295 Participants
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=308 Participants
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
|
-31.37 mmHg
Standard Error 0.90
|
-27.99 mmHg
Standard Error 0.88
|
-30.77 mmHg
Standard Error 0.88
|
-37.92 mmHg
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Outcome measures
| Measure |
Aliskiren / Amlodipine
n=282 Participants
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=296 Participants
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=295 Participants
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=308 Participants
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
|
-18.03 mmHg
Standard Error 0.57
|
-14.32 mmHg
Standard Error 0.55
|
-17.03 mmHg
Standard Error 0.55
|
-20.63 mmHg
Standard Error 0.54
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Blood pressure control was defined as a msSBP/msDBP \< 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.
Outcome measures
| Measure |
Aliskiren / Amlodipine
n=283 Participants
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=296 Participants
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=295 Participants
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=192 Participants
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
|
41.3 Percentage of patients
|
33.1 Percentage of patients
|
39.0 Percentage of patients
|
62.3 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.
Outcome measures
| Measure |
Aliskiren / Amlodipine
n=138 Participants
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=155 Participants
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=136 Participants
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=147 Participants
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
Systolic BP
|
-20.30 mmHg
Standard Error 0.52
|
-16.27 mmHg
Standard Error 0.51
|
-18.67 mmHg
Standard Error 0.53
|
-25.29 mmHg
Standard Error 0.51
|
|
Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
Diastolic BP
|
-13.29 mmHg
Standard Error 0.36
|
-9.57 mmHg
Standard Error 0.35
|
-11.20 mmHg
Standard Error 0.37
|
-15.90 mmHg
Standard Error 0.35
|
Adverse Events
Aliskiren / Amlodipine
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Aliskiren / Hydrochlorothiazide
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Amlodipine / Hydrochlorothiazide
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Aliskiren / Amlodipine / Hydrochlorothiazide
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren / Amlodipine
n=287 participants at risk
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=297 participants at risk
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=295 participants at risk
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=309 participants at risk
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Endocrine disorders
Goitre
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Infections and infestations
Hepatitis A
|
0.35%
1/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.34%
1/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.34%
1/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.35%
1/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.34%
1/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.34%
1/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.35%
1/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.00%
0/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
0.32%
1/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
Other adverse events
| Measure |
Aliskiren / Amlodipine
n=287 participants at risk
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Aliskiren / Hydrochlorothiazide
n=297 participants at risk
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
|
Amlodipine / Hydrochlorothiazide
n=295 participants at risk
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
Aliskiren / Amlodipine / Hydrochlorothiazide
n=309 participants at risk
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
|
|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
8.0%
23/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
2.0%
6/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
4.1%
12/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
7.1%
22/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
|
Nervous system disorders
Headache
|
3.1%
9/287 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
4.0%
12/297 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
5.1%
15/295 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
3.6%
11/309 • During the 8 week double blind treatment
Safety Set. All patients who received double-blind trial medication.
|
Additional Information
Study Director
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER