A Clinical Study to Evaluate the Long-Term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171405

Purpose

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A 4 Month Extension to a 12 Month, Randomized, Open-Label, Multicenter, Study to Assess the Long-Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:

Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study

Secondary Outcome Measures:

Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Blood pressure less than 140/90 mmHg

Estimated Enrollment:	250
Study Start Date:	February 2005

Eligibility

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

Criteria

Inclusion Criteria:

their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
absence of ongoing severe adverse events at Visit 10.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171405

Locations

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

Investigative Sites, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CSPP100A2302E1
Study First Received:	August 24, 2005
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00171405
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

hypertension
aliskiren
hydrochlorothiazide

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs

Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009