A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-Term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00386607

Purpose

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/HCTZ.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren/valsartan/HCTZ combination	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Hydrochlorothiazide Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-Label Extension to Assess the Long-Term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/HCTZ.

Further study details as provided by Novartis:

Primary Outcome Measures:

Assess long-term safety of the combination of aliskiren 300 mg/valsartan 320 mg in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mgHg). [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
2. Assess the safety and tolerability of the triple combination of aliskiren/valsartan/HCTZ (SVH) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1. To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/valsartan [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The proportion of patients achieving the blood pressure target of <140/90 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess the long-term blood pressure lowering efficacy of the triple combination of aliskiren/valsartan/HCTZ. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of the 6 month extension study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	601
Study Start Date:	October 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren/valsartan/HCTZ	Drug: Aliskiren/valsartan/HCTZ combination Aliskiren 300 mg/ Valsartan 320 mg/ HCTZ (12.5-25 mg)

Eligibility

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

Criteria

Inclusion Criteria: -

Male and female outpatients 18 years of age and older.
Patients who are eligible and able to participate in the study.

Patients will qualify to participate in the long-term extension based on:

Their successful completion of the CSPV100A2301 Core study.
Obtaining informed consent to participate in the extension study.
Absence of ongoing severe adverse events at final visit in core study.
Absence of hypotension (msSBP <100 mmHg or msDBP (<60 mmHg) or related events at final visit in the core study.
Absence of hypokalemia (clinical symptoms/signs or lab findings) at Visits 12 or 13.

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 may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386607

Locations

United States, New Jersey
Novartis Pharmaceuticals, various sites
East Hanover, New Jersey, United States, 07936
Canada
Investigative Centers
Canada, Canada
Germany
Investigative Centers
Germany, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPV100A2301
Study First Received:	October 10, 2006
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00386607
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension, aliskiren, valsartan, HCTZ, blood pressure

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009