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Trial record 4 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00386607
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : May 10, 2011
Last Update Posted : February 10, 2014
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE October 10, 2006
First Posted Date  ICMJE October 11, 2006
Results First Submitted Date  ICMJE December 20, 2010
Results First Posted Date  ICMJE May 10, 2011
Last Update Posted Date February 10, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
  • Overall Percentage of Patients With Adverse Events [ Time Frame: Month 12 ]
  • Overall Percentage of Patients With Adverse Events [ Time Frame: Month 18 ]
    adverse event data obtained from both the core study and the 6 month extension study.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
Safety of aliskiren and valsartan for 54 weeks
Change History Complete list of historical versions of study NCT00386607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]
  • Change From Baseline in Mean Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54 ]
  • Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg [ Time Frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
  • Change From Baseline in Mean Sitting Systolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
  • Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment [ Time Frame: Month 18 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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/Hydrochlorothiazide(HCTZ)
Brief Summary 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/Hydrochlorothiazide(HCTZ).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Aliskiren
    Aliskiren 300 mg
  • Drug: Valsartan
    Valsartan 320 mg
  • Drug: Hydrochlorothiazide (HCTZ)
    Hydrochlorothiazide (HCTZ) 12.5-25 mg
Study Arms  ICMJE
  • Experimental: Core Treatment
    Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
    Interventions:
    • Drug: Aliskiren
    • Drug: Valsartan
  • Experimental: Extension Treatment

    For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.

    The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.

    Interventions:
    • Drug: Aliskiren
    • Drug: Valsartan
    • Drug: Hydrochlorothiazide (HCTZ)
Publications * Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2008)
601
Original Enrollment  ICMJE
 (submitted: October 10, 2006)
500
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: -

  • Male and female outpatients 18 years of age and older.
  • For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
  • For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
  • Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

Exclusion Criteria:

  • Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
  • Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
  • History or evidence of a secondary form of hypertension.
  • History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00386607
Other Study ID Numbers  ICMJE CSPV100A2301
CSPV100A2301E1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2014

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