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Completed

NCT Number: NCT00386607

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.

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren

Drug

Aliskiren 300 mg

valsartan

Drug

Valsartan 320 mg

Hydrochlorothiazide (HCTZ)

Drug

Hydrochlorothiazide (HCTZ) 12.5-25 mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 11, 2006
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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