A Clinical Study to Evaluate the Long-Term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

Condition(s) targeted: Hypertension

Intervention: aliskiren (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

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

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Official title: A 4 Month Extension to a 12 Month, Randomized, Open-Label, Multicenter, Study to Assess the Long-Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study

Secondary outcome:

Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months

Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months

Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months

Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline

Blood pressure less than 140/90 mmHg

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

Criteria:

Inclusion Criteria: their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i. e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study. absence of ongoing severe adverse events at Visit 10.

Investigative Sites, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Starting date: February 2005
Last updated: November 9, 2006