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.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00294710

First received: February 18, 2006

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

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

Enrollment:	976
Study Start Date:	March 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. Epub 2009 Jan 12.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00294710 History of Changes
Other Study ID Numbers:	CSPP100A2323E
Study First Received:	February 18, 2006
Last Updated:	November 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, hydrochlorothiazide, amlodipine

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013

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