An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

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 / Amlodipine 10 mg in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402103
• Other study ID #: CSPA100A2301
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2006
• Last updated: March 8, 2011
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Ministry of Social Affairs, Public Health and the EnvironmentDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of HealthSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients 18 years of age or older

• Male or female patients are eligible

• 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)

Exclusion Criteria:

• Severe hypertension

• 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
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
• Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
• Hydrochlorothiazide
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Locations

Country	Name	City	State
Belgium	Investigator Site	Investigative Site
Denmark	Investigative Center	Investigative Center
Finland	Investigative Site	Investigative Site
Germany	Investigative Center	Investigative Center
Iceland	Investigative Site	Investigative Site
India	Investigative Site	Investigative Site
Switzerland	Investigative Site	Investigative Site
United States	Investigative Site	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Finland,  Germany,  Iceland,  India,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Percentage of Patients With Adverse Events		52 weeks	Yes
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points		Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54	No
Secondary	Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg		Baseline, Week 2, Week 10, Week 28 and Week 54	No
Secondary	Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)		Baseline, Week 2, Week 10, Week 28 and Week 54	No