Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren 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 (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777946
• Other study ID #: CSPA100A2303
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2008
• Last updated: June 30, 2011
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Iceland: Icelandic Medicines Control AgencyIndia: Ministry of HealthItaly: The Italian Medicines AgencyLithuania: State Medicine Control Agency - Ministry of HealthSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Spanish Agency of MedicinesVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: May 2009
• Est. primary completion date: May 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 mean sitting Diastolic Blood Pressure (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 4

Exclusion Criteria:

• Severe hypertension

• Pregnant or nursing (lactating) women

• Women of child-bearing potential

• Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)

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

• Uncontrolled Type 1 or Type 2 diabetes mellitus

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

• History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

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:
• Aliskiren 300 mg
Aliskiren 300 mg tablet taken orally once a day with a glass of water.
• Aliskiren/Amlodipine 300/5 mg
Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
• Aliskiren/Amlodipine 300/10 mg
Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
• Placebo to Aliskiren
Placebo to Aliskiren tablet taken orally once a day.
• Placebo to Aliskiren/Amlodipine
Placebo to Aliskiren/Amlodipine taken orally once a day.

Locations

Country	Name	City	State
Estonia	Investigative site	Estonia
France	Investigative site	France
Iceland	Investigative Site	Iceland
India	Investigative Site	India
Italy	Investigative site	Italy
Korea, Republic of	Investigative Site	Republic of Korea
Lithuania	Investigative Site	Lithuania
Spain	Investigative Site	Spain
Venezuela	Investigative Site	Venezuela

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Estonia,  France,  Iceland,  India,  Italy,  Korea, Republic of,  Lithuania,  Spain,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)	After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.	Baseline, End of Study (Week 8)	No
Secondary	Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)	After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.	Baseline, End of Study (Week 8)	No
Secondary	Number of Participants With Serious Adverse Events and Adverse Events	The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.; Additional information about Adverse Events can be found in the Adverse Event Section.	8 weeks	Yes
Secondary	Percentage of Participants Achieving Blood Pressure Control	After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.; Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140.	8 weeks	No
Secondary	Percentage of Participants Achieving a Diastolic Blood Pressure Response	After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.; A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a = 10 mmHg reduction in msDBP from baseline.	8 weeks	No
Secondary	Percentage of Participants Achieving a Systolic Blood Pressure Response	After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.; A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a = 20 mmHg reduction in msSBP from baseline.	8 weeks	No