Trial Outcomes & Findings for Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (NCT NCT00942994)
NCT ID: NCT00942994
Last Updated: 2011-06-08
Results Overview
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
412 participants
Primary outcome timeframe
Baseline and week 8
Results posted on
2011-06-08
Participant Flow
Participant milestones
| Measure |
Aliskiren / Amlodipine / HCTZ
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
209
|
|
Overall Study
COMPLETED
|
187
|
190
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Aliskiren / Amlodipine / HCTZ
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
1
|
|
Overall Study
Patient withdrew consent
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Protocol deviation
|
1
|
2
|
Baseline Characteristics
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.7 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Baseline [N=202, 209]
|
167.08 mmHg
Standard Deviation 7.277
|
167.41 mmHg
Standard Deviation 7.118
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Week 8 [N=197, 209]
|
130.73 mmHg
Standard Deviation 13.06
|
137.87 mmHg
Standard Deviation 16.013
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Change from baseline to week 8 [N=197, 209]
|
-36.43 mmHg
Standard Deviation 13.904
|
-29.54 mmHg
Standard Deviation 15.674
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.
To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Baseline [N=202, 209]
|
95.25 mmHg
Standard Deviation 8.985
|
95.25 mmHg
Standard Deviation 8.342
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Week 8 [N=197, 209]
|
80.10 mmHg
Standard Deviation 10.317
|
83.17 mmHg
Standard Deviation 10.116
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Change from baseline to week 8 [N=197, 209]
|
-15.10 mmHg
Standard Deviation 9.707
|
-12.08 mmHg
Standard Deviation 9.062
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.
To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP \<140 mmHg and MSDBP \<90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
Week 2
|
50.5 Percentage of Participants
|
40.2 Percentage of Participants
|
|
Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
Week 4
|
74.8 Percentage of Participants
|
57.4 Percentage of Participants
|
|
Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks
Week 8
|
81.7 Percentage of Participants
|
67.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.
To compare the cumulative percentage of responders (defined as patients with MSSBP \<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
Week 2
|
79.2 Percentage of Responders
|
72.2 Percentage of Responders
|
|
Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
Week 4
|
91.1 Percentage of Responders
|
84.7 Percentage of Responders
|
|
Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.
Week 8
|
92.6 Percentage of Responders
|
91.9 Percentage of Responders
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2 and Week 4Population: Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.
Primary objective at additional timepoint.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Baseline [N=202, 209]
|
167.08 mmHg
Standard Deviation 7.277
|
167.41 mmHg
Standard Deviation 7.118
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Change from baseline to week 4 [N=197, 209]
|
-34.74 mmHg
Standard Deviation 12.145
|
-26.98 mmHg
Standard Deviation 13.389
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Week 2 [N=197, 209]
|
138.35 mmHg
Standard Deviation 12.578
|
143.77 mmHg
Standard Deviation 13.922
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Change from baseline to week 2 [N=197, 209]
|
-28.81 mmHg
Standard Deviation 12.640
|
-23.64 mmHg
Standard Deviation 13.673
|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4
Week 4 [N=197, 209]
|
132.42 mmHg
Standard Deviation 12.027
|
140.43 mmHg
Standard Deviation 13.961
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 2 and Week 4Population: Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.
Secondary objective at additional timepoint.
Outcome measures
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 Participants
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 Participants
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Baseline [N=202, 209]
|
95.25 mmHg
Standard Deviation 8.985
|
95.25 mmHg
Standard Deviation 8.342
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Week 2 [N=197, 209]
|
84.26 mmHg
Standard Deviation 9.597
|
86.24 mmHg
Standard Deviation 8.908
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Change from baseline to week 4 [N=197, 209]
|
-13.92 mmHg
Standard Deviation 8.891
|
-9.91 mmHg
Standard Deviation 7.606
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Change from baseline to week 2 [N=197, 209]
|
-10.95 mmHg
Standard Deviation 8.569
|
-9.01 mmHg
Standard Deviation 7.872
|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4
Week 4 [N=197, 209]
|
81.29 mmHg
Standard Deviation 9.177
|
85.35 mmHg
Standard Deviation 9.567
|
Adverse Events
Aliskiren / Amlodipine / HCTZ
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Aliskiren / Amlodipine
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 participants at risk
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 participants at risk
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/202 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
0.48%
1/209 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
0.48%
1/209 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/202 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
0.48%
1/209 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/202 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
0.48%
1/209 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
Other adverse events
| Measure |
Aliskiren / Amlodipine / HCTZ
n=202 participants at risk
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
|
Aliskiren / Amlodipine
n=209 participants at risk
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.9%
22/202 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.
|
8.6%
18/209 • 8 weeks
AEs were analyzed in the Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study 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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER