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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.
This study has been completed.
Study NCT00386607   Information provided by Novartis
First Received: October 10, 2006   Last Updated: December 5, 2008   History of Changes

October 10, 2006
December 5, 2008
October 2006
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
Safety of aliskiren and valsartan for 54 weeks
Complete list of historical versions of study NCT00386607 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean sitting diastolic blood pressure (msDBP) lowering efficacy of the combination of aliskiren and valsartan from baseline to week 54
  • Achieving blood pressure control target of <140/90 mmHg at end of study
 
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.
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.

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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Hypertension
Drug: Aliskiren/valsartan/HCTZ combination
Experimental: Aliskiren/valsartan/HCTZ
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
601
 
March 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany
 
NCT00386607
External Affairs, Novartis
CSPV100A2301
Novartis
 
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP