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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.

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Drug: Valsartan Drug: Hydrochlorothiazide (HCTZ) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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/Hydrochlorothiazide(HCTZ)
Study Start Date : October 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Aliskiren
Aliskiren 300 mg

Drug: Valsartan
Valsartan 320 mg
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.

 Drug: Aliskiren
Aliskiren 300 mg

Drug: Valsartan
Valsartan 320 mg

Drug: Hydrochlorothiazide (HCTZ)
Hydrochlorothiazide (HCTZ) 12.5-25 mg


Outcome Measures
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Primary Outcome Measures :
  1. Overall Percentage of Patients With Adverse Events [ Time Frame: Month 12 ]
  2. 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.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ]
  2. Change From Baseline in Mean Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54 ]
  3. 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 ]
  4. Change From Baseline in Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
  5. Change From Baseline in Mean Sitting Systolic Blood Pressure [ Time Frame: Baseline and Month 18 ]
  6. Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment [ Time Frame: Month 18 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386607


Locations
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United States, California
Investigative Centers
San Diego, California, United States
Canada
Investigative Centers
Canada, Canada
Germany
Investigative Centers
Germany, Germany
Netherlands
Investigative Centers
Netherlands, Netherlands
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00386607     History of Changes
Other Study ID Numbers: CSPV100A2301
CSPV100A2301E1
First Posted: October 11, 2006    Key Record Dates
Results First Posted: May 10, 2011
Last Update Posted: February 10, 2014
Last Verified: January 2014
Keywords provided by Novartis:
Hypertension, aliskiren, valsartan, HCTZ, blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators