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.

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386607
• Other study ID #: CSPV100A2301
• Secondary ID: CSPV100A2301E1
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2006
• Last updated: January 14, 2014
• Start date: October 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren
Aliskiren 300 mg
• Valsartan
Valsartan 320 mg
• Hydrochlorothiazide (HCTZ)
Hydrochlorothiazide (HCTZ) 12.5-25 mg

Locations

Country	Name	City	State
Canada	Investigative Centers	Canada
Germany	Investigative Centers	Germany
Netherlands	Investigative Centers	Netherlands
United States	Investigative Centers	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Percentage of Patients With Adverse Events		Month 12	Yes
Primary	Overall Percentage of Patients With Adverse Events	adverse event data obtained from both the core study and the 6 month extension study.	Month 18	Yes
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure.		Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54	No
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure.		Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54	No
Secondary	Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg		.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure		Baseline and Month 18	No
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure		Baseline and Month 18	No
Secondary	Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment		Month 18	No