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

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

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

NCT00171405•Novartis

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Investigative Site

Broni, Italy

Investigative Site

Rotterdam, Netherlands

Investigative Site

Lima, Peru

Investigative Site

Moscow, Russia

Investigative Site

Basel, Switzerland

Investigative Site

London, United Kingdom

Key Dates

Start Date

June 1, 2005

Primary Completion Date

February 1, 2006

Completion Date

February 1, 2006

Last Updated

November 18, 2016

Enrollment

250

Estimated participants

Conditions

Hypertension

Interventions

aliskiren

DRUG

Natural History of Noncirrhotic Portal Hypertension

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Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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