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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00386607
First received: October 10, 2006
Last updated: January 14, 2014
Last verified: January 2014
  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/Hydrochlorothiazide(HCTZ).


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Drug: Valsartan
Drug: Hydrochlorothiazide (HCTZ)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Percentage of Patients With Adverse Events [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Overall Percentage of Patients With Adverse Events [ Time Frame: Month 18 ] [ Designated as safety issue: Yes ]
    adverse event data obtained from both the core study and the 6 month extension study.


Secondary Outcome Measures:
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54 ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Sitting Systolic Blood Pressure [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment [ Time Frame: Month 18 ] [ Designated as safety issue: No ]

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

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

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00386607     History of Changes
Other Study ID Numbers: CSPV100A2301, CSPV100A2301E1
Study First Received: October 10, 2006
Results First Received: December 20, 2010
Last Updated: January 14, 2014
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014