Trial Outcomes & Findings for Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension (NCT NCT00853957)

NCT ID: NCT00853957

Last Updated: 2012-04-30

Results Overview

To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 443 participants
• Primary outcome timeframe: Baseline, 8 weeks
• Results posted on: 2012-04-30

Participant Flow

Participant milestones

Measure	Aliskiren/Amlodipine Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine Amlodipine 5mg titrated to 10 mg
Overall Study STARTED	220	223
Overall Study COMPLETED	206	204
Overall Study NOT COMPLETED	14	19

Reasons for withdrawal

Measure	Aliskiren/Amlodipine Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine Amlodipine 5mg titrated to 10 mg
Overall Study Adverse Event	9	3
Overall Study Unsatisfactory therapeutic effect	0	2
Overall Study Subject withdrew consent	4	5
Overall Study Lost to Follow-up	1	6
Overall Study Protocol deviation	0	3

Baseline Characteristics

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Baseline characteristics by cohort

Measure	Aliskiren/Amlodipine n=220 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=223 Participants Amlodipine 5mg titrated to 10 mg	Total n=443 Participants Total of all reporting groups
Age Continuous	53.2 years STANDARD_DEVIATION 9.33 • n=5 Participants	52.4 years STANDARD_DEVIATION 10.57 • n=7 Participants	52.8 years STANDARD_DEVIATION 9.97 • n=5 Participants
Age, Customized <55 years	123 participants n=5 Participants	127 participants n=7 Participants	250 participants n=5 Participants
Age, Customized ≥55 years	97 participants n=5 Participants	96 participants n=7 Participants	193 participants n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	115 Participants n=7 Participants	238 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	108 Participants n=7 Participants	205 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Population: Full analysis set, Last Observation Carried Forward (LOCF)

To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.

Outcome measures

Measure	Aliskiren/Amlodipine n=220 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=222 Participants Amlodipine 5mg titrated to 10 mg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	-33.1 mm Hg Standard Deviation 14.53	-27.8 mm Hg Standard Deviation 13.45

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Full analysis set, Last Observation Carried Forward (LOCF)

To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).

Outcome measures

Measure	Aliskiren/Amlodipine n=220 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=222 Participants Amlodipine 5mg titrated to 10 mg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	-13.7 mm Hg Standard Deviation 9.60	-10.4 mm Hg Standard Deviation 9.08

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set

Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

Outcome measures

Measure	Aliskiren/Amlodipine n=206 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=204 Participants Amlodipine 5mg titrated to 10 mg
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)	71.4 Percentage of participants	57.4 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set

Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

Outcome measures

Measure	Aliskiren/Amlodipine n=206 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=204 Participants Amlodipine 5mg titrated to 10 mg
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)	92.3 Percentage of participants	86.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 1 and 4 weeks

Population: Full analysis set, Last Observation Carried Forward (LOCF)

Compare the change from baseline in MSSBP at week 1 and 4

Outcome measures

Measure	Aliskiren/Amlodipine n=215 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=219 Participants Amlodipine 5mg titrated to 10 mg
Change From Baseline in MSSBP at Week 1 and 4 Baseline to Week 1	-20.5 mm Hg Standard Deviation 12.53	-18.2 mm Hg Standard Deviation 13.01
Change From Baseline in MSSBP at Week 1 and 4 baseline to Week 4	-30.9 mm Hg Standard Deviation 13.30	-27.3 mm Hg Standard Deviation 13.58

SECONDARY outcome

Timeframe: 8 weeks

Population: Full Analysis Set

Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.

Outcome measures

Measure	Aliskiren/Amlodipine n=220 Participants Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=223 Participants Amlodipine 5mg titrated to 10 mg
Percentage of Patients With Peripheral Edema by Visit Week 1	1.4 Percentage of participants	1.3 Percentage of participants
Percentage of Patients With Peripheral Edema by Visit Week 4	4.1 Percentage of participants	5.8 Percentage of participants
Percentage of Patients With Peripheral Edema by Visit Week 8	6.8 Percentage of participants	8.5 Percentage of participants

Adverse Events

Aliskiren/Amlodipine

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Amlodipine

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren/Amlodipine n=220 participants at risk Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=223 participants at risk Amlodipine 5mg titrated to 10 mg
Cardiac disorders Angina unstable	0.45% 1/220 • 8 weeks	0.00% 0/223 • 8 weeks
Infections and infestations Pneumonia	0.00% 0/220 • 8 weeks	0.45% 1/223 • 8 weeks
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/220 • 8 weeks	0.45% 1/223 • 8 weeks

Other adverse events

Measure	Aliskiren/Amlodipine n=220 participants at risk Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Amlodipine n=223 participants at risk Amlodipine 5mg titrated to 10 mg
General disorders Oedema peripheral	7.7% 17/220 • 8 weeks	9.0% 20/223 • 8 weeks
Nervous system disorders Headache	3.6% 8/220 • 8 weeks	5.4% 12/223 • 8 weeks

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