Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-06-30

Brief Summary

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To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

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Detailed Description

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NCT00415623 (protocol A0531085)

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Interventions

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Amlodipine

Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
* Patients who had a treatment compliance rate of at least 80%