Trial Outcomes & Findings for Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population (NCT NCT00760266)

NCT ID: NCT00760266

Last Updated: 2011-04-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 451 participants
• Primary outcome timeframe: Baseline and Week 4
• Results posted on: 2011-04-04

Participant Flow

Participant milestones

Measure	Aliskiren/HCTZ Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Overall Study STARTED	228	223
Overall Study COMPLETED	204	205
Overall Study NOT COMPLETED	24	18

Reasons for withdrawal

Measure	Aliskiren/HCTZ Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Overall Study Adverse Event	13	7
Overall Study Abnormal laboratory value(s)	1	0
Overall Study Abnormal test procedure result(s)	1	0
Overall Study Lack of Efficacy	2	2
Overall Study Protocol deviation	2	4
Overall Study Patient withdrew consent	3	3
Overall Study Lost to Follow-up	2	1
Overall Study Administrative Problems	0	1

Baseline Characteristics

Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

Baseline characteristics by cohort

Measure	Aliskiren/HCTZ n=228 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=223 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks	Total n=451 Participants Total of all reporting groups
Age Continuous	64.5 years STANDARD_DEVIATION 7.57 • n=5 Participants	65.1 years STANDARD_DEVIATION 6.96 • n=7 Participants	64.8 years STANDARD_DEVIATION 7.27 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	100 Participants n=7 Participants	227 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	123 Participants n=7 Participants	224 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set

Outcome measures

Measure	Aliskiren/HCTZ n=225 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=222 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4	-29.6 mm Hg Standard Error 1.0	-22.3 mm Hg Standard Error 1.0

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set, restricted to baseline msDBP \>= 90 mmHg

Outcome measures

Measure	Aliskiren/HCTZ n=130 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=133 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4	-11.1 mm Hg Standard Error 0.8	-9.2 mm Hg Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)

Outcome measures

Measure	Aliskiren/HCTZ n=225 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=222 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 msSBP	-33.2 mm Hg Standard Error 1.0	-25.7 mm Hg Standard Error 1.0
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 msDBP (N = 130 , 133)	-13.3 mm Hg Standard Error 0.8	-10.1 mm Hg Standard Error 0.8

SECONDARY outcome

Timeframe: At 4 weeks and 8 weeks

Population: Full analysis set

Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline

Outcome measures

Measure	Aliskiren/HCTZ n=225 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=222 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Percentage of Responders at Week 4 and Week 8 Week 4	73.3 Percentage of Participants	55.9 Percentage of Participants
Percentage of Responders at Week 4 and Week 8 Week 8	83.1 Percentage of Participants	67.6 Percentage of Participants

SECONDARY outcome

Timeframe: At Weeks 4 and 8

Population: Full analysis set

Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg

Outcome measures

Measure	Aliskiren/HCTZ n=225 Participants Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=222 Participants Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 week 4	49.8 Percentage of Participants	33.3 Percentage of Participants
Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 week 8	62.2 Percentage of Participants	39.2 Percentage of Participants

Adverse Events

Aliskiren / HCTZ

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

HCTZ

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren / HCTZ n=227 participants at risk Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=223 participants at risk HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Gastrointestinal disorders Colitis	0.44% 1/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.00% 0/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
General disorders Non-cardiac chest pain	0.00% 0/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.45% 1/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.45% 1/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.45% 1/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Investigations Renal function test abnormal	0.44% 1/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.00% 0/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.44% 1/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.00% 0/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Nervous system disorders Cerebrovascular accident	0.44% 1/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	0.00% 0/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.

Other adverse events

Measure	Aliskiren / HCTZ n=227 participants at risk Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks	HCTZ n=223 participants at risk HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
Nervous system disorders Dizziness	5.7% 13/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	4.0% 9/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
Nervous system disorders Headache	1.8% 4/227 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.	7.6% 17/223 One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.

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