Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」

NCT ID: NCT02211638

Last Updated: 2018-11-05

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

18113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-13

Study Completion Date

2013-04-25

Brief Summary

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The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.

Detailed Description

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This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure.

The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.

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 tablets (2 to 12 mg)

Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months

Candesartan Cilexetil

Intervention Type DRUG

Candesartan Cilexetil tablet

Interventions

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Candesartan Cilexetil

Candesartan Cilexetil tablet

Intervention Type DRUG

Other Intervention Names

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Blopress

Eligibility Criteria

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Inclusion Criteria

* Hypertensive patients

Exclusion Criteria

1. Inpatients
2. Patients under dialysis (planned)
3. Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
4. Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
5. Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
6. Patients who are pregnant or may possibly become pregnant
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

Locations

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Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-132380

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-R171021

Identifier Type: OTHER

Identifier Source: secondary_id

460-017

Identifier Type: -

Identifier Source: org_study_id

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