Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

NCT ID: NCT02068495

Last Updated: 2018-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-15

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.

Detailed Description

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This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.

The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Candesartan cilexetil/Amlodipine besilate

8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily

Candesartan cilexetil/Amlodipine besilate

Intervention Type DRUG

Candesartan cilexetil/Amlodipine besilate tablets

Interventions

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Candesartan cilexetil/Amlodipine besilate

Candesartan cilexetil/Amlodipine besilate tablets

Intervention Type DRUG

Other Intervention Names

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Unisia Combination Tablets

Eligibility Criteria

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Inclusion Criteria

1\. Participants with hypertension

Exclusion Criteria

1. Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated \[Contraindications\]
2. Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations
3. Women who are pregnant or of child-bearing potential
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

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JapicCTI-132390

Identifier Type: REGISTRY

Identifier Source: secondary_id

119-011

Identifier Type: -

Identifier Source: org_study_id

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