Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT01237223

Recruitment Status : Completed

First Posted : November 9, 2010

Results First Posted : June 13, 2012

Last Update Posted : June 13, 2012

Sponsor:

Information provided by (Responsible Party):

Novartis

Study Description

Brief Summary:

The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110 mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: Aliskiren/Amlodipine 150/2.5 mg Drug: Aliskiren/amlodipine 150/5 mg Drug: Aliskiren 150 mg Drug: Amlodipine 2.5 mg Drug: Placebo of Aliskiren Drug: Placebo of Amlodipine Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Drug: Placebo of Aliskiren/amlodipine 150/5 mg	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1342 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension
Study Start Date :	October 2010
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.	Drug: Placebo of Aliskiren Aliskiren placebo tablet Drug: Placebo of Amlodipine Amlodipine placebo capsule Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg placebo tablet Drug: Placebo of Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg placebo tablet
Active Comparator: Aliskiren 150 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.	Drug: Aliskiren 150 mg Aliskiren 150 mg tablet Drug: Placebo of Amlodipine Amlodipine placebo capsule Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg placebo tablet Drug: Placebo of Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg placebo tablet
Active Comparator: Amlodipine 2.5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.	Drug: Amlodipine 2.5 mg Amlodipine 2.5 mg capsule Drug: Placebo of Aliskiren Aliskiren placebo tablet Drug: Placebo of Amlodipine Amlodipine placebo capsule Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg placebo tablet Drug: Placebo of Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg placebo tablet
Active Comparator: Amlodipine 5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.	Drug: Amlodipine 2.5 mg Amlodipine 2.5 mg capsule Drug: Placebo of Aliskiren Aliskiren placebo tablet Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg placebo tablet Drug: Placebo of Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg placebo tablet
Experimental: Aliskiren/amlodipine 150/2.5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.	Drug: Aliskiren/Amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg tablet Drug: Placebo of Aliskiren Aliskiren placebo tablet Drug: Placebo of Amlodipine Amlodipine placebo capsule Drug: Placebo of Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg placebo tablet
Experimental: Aliskiren/amlodipine 150/5 mg In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.	Drug: Aliskiren/amlodipine 150/5 mg Aliskiren/amlodipine 150/5 mg tablet Drug: Placebo of Aliskiren Aliskiren placebo tablet Drug: Placebo of Amlodipine Amlodipine placebo capsule Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Aliskiren/amlodipine 150/2.5 mg placebo tablet

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) [ Time Frame: Baseline, Week 8 ]
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.

Secondary Outcome Measures :

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) [ Time Frame: Baseline, Week 8 ]
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Percentage of Participants Achieving Blood Pressure Control at Endpoint [ Time Frame: 8 weeks ]
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
Percentage of Participants Achieving a Successful Response Rate [ Time Frame: 8 weeks ]
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
Number of Participants With Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ]
Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
Outpatients

Exclusion Criteria:

Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
History or evidence of a secondary hypertension

Other protocol-defined inclusion/exclusion criteria applied

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237223

Locations

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Japan
Investigative Site
Aichi, Japan
Investigative Site
Ehime, Japan
Investigative Site
Fukuoka, Japan
Investigative Site
Hokkaido, Japan
Investigative Site
Hyogo, Japan
Investigative Site
Kanagawa, Japan
Investigative Site
Kyoto, Japan
Investigative Site
Okayama, Japan
Investigative Site
Osaka, Japan
Investigative Site
Saitama, Japan
Investigative Site
Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01237223
Other Study ID Numbers:	CSPA100A1301
First Posted:	November 9, 2010 Key Record Dates
Results First Posted:	June 13, 2012
Last Update Posted:	June 13, 2012
Last Verified:	May 2012

Keywords provided by Novartis:


Aliskiren Amlodipine Essential hypertension

Additional relevant MeSH terms:

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Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Antihypertensive Agents	Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents

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