Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension - Full Text View

Purpose

This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Condition	Intervention	Phase
Moderate to Severe Hypertension	Drug: Aliskiren/amlodipine 300/10 mg tablet Drug: Amlodipine 10 mg capsule	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)

Secondary Outcome Measures:

Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)
Systolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)
Diastolic Blood Pressure Response [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]
Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)
Blood Pressure Control [ Time Frame: End of study (Week 8) ] [ Designated as safety issue: No ]
Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study

Enrollment:	485
Study Start Date:	January 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aliskiren/amlodipine 300/10 mg tablet Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.	Drug: Aliskiren/amlodipine 300/10 mg tablet Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
Active Comparator: Amlodipine 10 mg capsule Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.	Drug: Amlodipine 10 mg capsule Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Arms

Assigned Interventions

Experimental: Aliskiren/amlodipine 300/10 mg tablet

Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.

Drug: Aliskiren/amlodipine 300/10 mg tablet

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Active Comparator: Amlodipine 10 mg capsule

Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.

Drug: Amlodipine 10 mg capsule

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients ≥ 18 years of age
Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2

Exclusion Criteria:

Mild to moderate 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
Patients on a combination of 3 or more antihypertensive medications

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841672

Locations

Germany
Investigative Site
Berlin, Germany
Philippines
Investigative Site
Manilla, Philippines
Romania
Investigative Site
Bucharest, Romania
Russian Federation
Investigative Site
Moscow, Russian Federation
Singapore
Investigative Site
Singapore, Singapore
Spain
Investigative Site
Madrid, Spain

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00841672 History of Changes
Other Study ID Numbers:	CSPA100A2306
Study First Received:	February 10, 2009
Results First Received:	January 5, 2011
Last Updated:	July 5, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Philippines: Bureau of Food and Drugs Spain: Spanish Agency of Medicines Romania: National Medicines Agency

Keywords provided by Novartis:

Hypertension
systolic blood pressure
cardiovascular disease
aliskiren
amlodipine

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013