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COMPLETEDPHASE3

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension

NCT00705575•Novartis

View on ClinicalTrials.gov

Summary

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatients ≥18 years of age.
•Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and \< 180 mmHg at Visit 2.

Exclusion Criteria

•Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
•Secondary form of hypertension.
•Current diagnosis of heart failure (New York Heart Association \[NYHA\] Class II-IV).
•Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
•Second or third degree heart block without a pacemaker.
•Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
•Clinically significant valvular heart disease.
•Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
•Known Keith-Wagener grade III or IV hypertensive retinopathy.
•In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
+6 more criteria

Locations (8)

Investigative Site

East Hanover, New Jersey, United States

Investigative Site

Buenos Aires, Argentina

Investigative Site

Quito, Ecuador

Investigative Site

Berlin, Germany

Investigative Site

Guatemala City, Guatemala

Investigative Site

Rome, Italy

Investigative Site

Basel, Switzerland

Investigative Site

Ankara, Turkey (Türkiye)

Key Dates

Start Date

June 1, 2008

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

May 30, 2011

Enrollment

688

ACTUAL participants

Conditions

Hypertension

Interventions

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

DRUG

Aliskiren (300 mg)

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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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: May 30, 2011Data 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

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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