A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

This study has been completed.

First Received: September 12, 2005 Last Updated: June 1, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219063

Purpose

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Condition	Intervention	Phase
Hypertension.	Drug: aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 26 Week, Double-Blind, Randomized, Multicenter, Parallel Group, Active-Controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-Blind, Randomized, Placebo-Controlled Withdrawal in Patients With Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Ramipril Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in diastolic blood pressure after 26 weeks

Secondary Outcome Measures:

Change from baseline in systolic blood pressure after 26 weeks
Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks
Change from baseline in systolic blood pressure after 6 weeks and 12 weeks
Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

Estimated Enrollment:

846

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients with essential hypertension
Patients who are eligible and able to participate in the study

Exclusion Criteria

Severe hypertension
History or evidence of a secondary form of hypertension
History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219063

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CSPP100A2306
Study First Received:	September 12, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00219063 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Ramipril
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010