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.

January 14, 2014 updated by: Novartis

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Canada, Canada
        • Investigative Centers
  • Germany
      • Germany, Germany
        • Investigative Centers
  • Netherlands
      • Netherlands, Netherlands
        • Investigative Centers
  • United States
    • California
      • San Diego, California, United States
        • Investigative Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Percentage of Patients With Adverse Events
Time Frame: Month 12
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.
Month 18

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPV100A2301
  • CSPV100A2301E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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