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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ali/Amlo

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Group Type EXPERIMENTAL

Ali/Amlo 150/2.5 mg

Intervention Type DRUG

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Interventions

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Ali/Amlo 150/2.5 mg

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients that complete CSPA100A1301 study
* Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria

* Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
* Presence of major protocol violation in CSPA100A1301 study

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No