Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

This study has been completed.

First Received on October 11, 2006. Last Updated on July 16, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00387517

Purpose

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren/HCTZ	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	An Eight-Week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary Outcome Measures:

Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
Safety and tolerability
Proportion of patients achieving a blood pressure control target at week 8

Estimated Enrollment:	726
Study Start Date:	October 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Male or female outpatients 18 years old or older.
Patients with a diagnosis of hypertension defined as follows:
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
- All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
- All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.
Patients who are eligible and consent to participate in the study

Exclusion Criteria:

Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
Previous or current diagnosis of heart failure.
History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387517

Locations

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

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00387517 History of Changes
Other Study ID Numbers:	CSPP100A2333
Study First Received:	October 11, 2006
Last Updated:	July 16, 2008
Health Authority:	Iceland: Icelandic Medicines Control Agency; France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration

Keywords provided by Novartis:

Diastolic
systolic
hypertension
aliskiren

blood pressure
hydrochlorothiazide
HCTZ

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
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

ClinicalTrials.gov processed this record on February 09, 2012