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

NCT ID: NCT01237223

Last Updated: 2012-06-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo of Aliskiren

Intervention Type DRUG

Aliskiren placebo tablet

Placebo of Amlodipine

Intervention Type DRUG

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

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.

Group Type ACTIVE_COMPARATOR

Aliskiren 150 mg

Intervention Type DRUG

Aliskiren 150 mg tablet

Placebo of Amlodipine

Intervention Type DRUG

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

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.

Group Type ACTIVE_COMPARATOR

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg capsule

Placebo of Aliskiren

Intervention Type DRUG

Aliskiren placebo tablet

Placebo of Amlodipine

Intervention Type DRUG

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

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.

Group Type ACTIVE_COMPARATOR

Amlodipine 2.5 mg

Intervention Type DRUG

Amlodipine 2.5 mg capsule

Placebo of Aliskiren

Intervention Type DRUG

Aliskiren placebo tablet

Placebo of Aliskiren/amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

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.

Group Type EXPERIMENTAL

Aliskiren/Amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg tablet

Placebo of Aliskiren

Intervention Type DRUG

Aliskiren placebo tablet

Placebo of Amlodipine

Intervention Type DRUG

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

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.

Group Type EXPERIMENTAL

Aliskiren/amlodipine 150/5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg tablet

Placebo of Aliskiren

Intervention Type DRUG

Aliskiren placebo tablet

Placebo of Amlodipine

Intervention Type DRUG

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mg

Intervention Type DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Interventions

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Aliskiren/Amlodipine 150/2.5 mg

Aliskiren/amlodipine 150/2.5 mg tablet

Intervention Type DRUG

Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/5 mg tablet

Intervention Type DRUG

Aliskiren 150 mg

Aliskiren 150 mg tablet

Intervention Type DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg capsule

Intervention Type DRUG

Placebo of Aliskiren

Aliskiren placebo tablet

Intervention Type DRUG

Placebo of Amlodipine

Amlodipine placebo capsule

Intervention Type DRUG

Placebo of Aliskiren/amlodipine 150/2.5 mg

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Intervention Type DRUG

Placebo of Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/5 mg placebo tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Site

Aichi, , Japan

Site Status

Investigative Site

Ehime, , Japan

Site Status

Investigative Site

Fukuoka, , Japan

Site Status

Investigative Site

Hokkaido, , Japan

Site Status

Investigative Site

Hyōgo, , Japan

Site Status

Investigative Site

Kanagawa, , Japan

Site Status

Investigative Site

Kyoto, , Japan

Site Status

Investigative Site

Okayama, , Japan

Site Status

Investigative Site

Osaka, , Japan

Site Status

Investigative Site

Saitama, , Japan

Site Status

Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CSPA100A1301

Identifier Type: -

Identifier Source: org_study_id

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