Safety and Efficacy of Aliskiren + Hydrochlorothiazide in Patients With Moderate Hypertension

Condition(s) targeted: Hypertension

Intervention: Aliskiren /hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Overall contact:
Novartis, Phone: +41-61-324-1111

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication.

Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg

Study design: Treatment, Open Label, Single Group Assignment

Primary outcome: Mean diastolic blood pressure reduction

Secondary outcome:

Mean systolic blood pressure reduction

Responder rate for blood pressure

Normalization rate for blood pressure

Safety and tolerability (e.g. AEs, laboratory, physical examinations)

Changes in heart rate

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and < 110 mmHg

Exclusion Criteria:

- Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood

pressure ≥ 180 mmHg

- Patients with prior stroke, hypertensive encephalopathy or heart attack

- Patients with type 1 diabetes mellitus

- Patients with type 2 diabetes mellitus with poor glucose control

- Other protocol-defined inclusion/exclusion criteria may apply

Novartis, Phone: +41-61-324-1111

Investigative Site, Chemnitz, Germany; Recruiting
Novartis, Phone: +41-61-324-1111

Starting date: March 2009
Last updated: October 15, 2009