Clinical trial NCT01259297
Conditions: Cardiovascular Events
Keywords: Aliskiren Elderly Major Cardiovascular Events Effect of aliskiren-based regimen on major CV events (composite of CV death, non-fatal MI, non-fatal stroke and significant heart failure) in the elderly
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2012-11-01
Enrollment: 2336 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

Detailed description:
This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.

Arms: arm 1: In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.

In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.

Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period. arm 2: In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.

In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.

Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily. arm 3: In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.

In double blind period, randomized patients to this arm received Aliskiren 300 mg + Placebo for Amlodipine 5 mg arm 4: In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.

In double blind period, randomized patients to this arm received Aliskiren 300 mg + Placebo for HCTZ 25 mg once daily arm 5: In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.

In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily arm 6: In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.

In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily arm 7: In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.

In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily arm 8: In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.

In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide (HCTZ) intervention 4: Placebo for Aliskiren intervention 5: Placebo for Amlodipine intervention 6: Placebo for Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Aliskiren 150/300 mg once daily intervention 2: Amlodipine 5 mg intervention 3: HCTZ 12.5/25 mg intervention 4: Placebo for Aliskiren 300 mg intervention 5: Placebo for Amlodipine intervention 6: Placebo for HCTZ 12.5/25 mg

Protocol documents: