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

Novartis250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. absence of ongoing severe adverse events at Visit 10.

Locations (10)

Investigative Site

East Hanover, New Jersey, United States

Investigative Site

Deurne, Belgium

Investigative Site

Ste-Fov, Canada

Investigative Site

Krassel, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.