A Clinical Study to Compare Long-Term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00294710

Purpose

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Twenty Six-Week, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in diastolic blood pressure after 52 weeks

Secondary Outcome Measures:

Change from baseline in systolic and diastolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
Achieve blood pressure control target of < 140/90 mmHg after 12 weeks

Estimated Enrollment:	1100
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with essential hypertension

Exclusion Criteria:

Severe hypertension
History or evidence of a secondary form of hypertension
History of myocardial infarction.
Other protocol-defined inclusion exclusion criteria also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294710

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CSPP100A2323E
Study First Received:	February 18, 2006
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00294710
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, hydrochlorothiazide, amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension

Hydrochlorothiazide
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009