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

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan cilexetil/Amlodipine besilate

• Registration Number: NCT02068495
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-06-15
• Primary Completion: 2013-05-31
• Study Completion: 2013-05-31
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Results First Submitted: 2017-10-16
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-25
• Last Update Submitted: 2018-07-25
• Results First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3409

Inclusion Criteria

1. Participants with hypertension

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Candesartan cilexetil/Amlodipine besilate	Candesartan cilexetil/Amlodipine besilate	8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Events	Up to 12 Months
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)	Up to 12 Months	ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment	Baseline and final assessment (up to 12 Months)	Reported data are changes in DBP from baseline at final assessment (up to 12 months).
Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment	Baseline and final assessment (up to 12 Months)	Reported data are changes in SBP from baseline at final assessment (up to 12 months).
Changes From Baseline in Pulse Rate at Final Assessment	Baseline and final assessment (up to 12 Months)	Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment	Baseline and final assessment (up to 12 Months)	Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg.