Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Hypertension Clinical Trial

Official title:

A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778921
• Other study ID #: CSPA100A2304
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2008
• Last updated: February 25, 2011
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products AgencySlovakia: State Institute for Drug ControlTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP = 95 mmHg and < 110 mmHg at Visits 1 and 2

• Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP = 90 mmHg and < 110 mmHg at Visit 2

• All patients must have a msDBP = 90 mmHg and < 110 mmHg at Visit 5 (randomization)

Exclusion Criteria:

• Severe hypertension

• Pregnant or nursing (lactating) women

• Pre-menopausal women not taking accepted form of birth control

• Serum potassium = 5.3 mEq/L (mmol/L) at Visit 1

• History of cardiovascular conditions

• Uncontrolled Type 1 or Type 2 diabetes mellitus

• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amlodipine 10 mg
Amlodipine 10 mg
• Aliskiren 150
Aliskiren/Amlodipine 150/10 mg
• Amlodipine 300
Aliskiren/Amlodipine 300/10 mg

Locations

Country	Name	City	State
Argentina	Investigative Site	Buenos Aires
Germany	Investigative Site	Berlin
Norway	Investigative Site	Oslo
Poland	Investigative Site	Warsaw
Slovakia	Investigative Site	Bratislava
Sweden	Investigative Site	Stockholm
Turkey	Investigative Site	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Argentina,  Germany,  Norway,  Poland,  Slovakia,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study		Baseline and Week 8	No
Secondary	Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study		Baseline and Week 8	No
Secondary	Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group		8 weeks	Yes
Secondary	Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)		12 weeks	No