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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.

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Valsartan (Drug); Hydrochlorothiazide (HCTZ) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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).

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Overall Percentage of Patients With Adverse Events

Overall Percentage of Patients With Adverse Events

Secondary outcome:

Change From Baseline in Mean Sitting Diastolic Blood Pressure.

Change From Baseline in Mean Sitting Systolic Blood Pressure.

Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg

Change From Baseline in Mean Sitting Diastolic Blood Pressure

Change From Baseline in Mean Sitting Systolic Blood Pressure

Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Investigative Centers, Canada, Canada

Investigative Centers, Germany, Germany

Investigative Centers, Netherlands, Netherlands

Investigative Centers, San Diego, California, United States

Additional Information

Starting date: October 2006
Last updated: January 14, 2014

Page last updated: August 23, 2015

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