Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Hypertension
Interventions
DRUG

Candesartan+HCTZ - Phase 1

4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.

DRUG

Aliskiren+HCTZ - Phase 2

Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.

DRUG

Aliskiren+HCTZ+amlodipine - Phase 3

The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.

Trial Locations (1)

Unknown

Investigative Site, Chemnitz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY