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Completed

NCT Number: NCT02068495

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with hypertension

Exclusion criteria

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

Treatment and study plan

Candesartan cilexetil/Amlodipine besilate

Drug

Candesartan cilexetil/Amlodipine besilate tablets

Other names: Unisia Combination Tablets

Primary outcomes

  1. Number of Participants Who Experience at Least One Adverse Events

    Time frame: Up to 12 Months

  2. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

    Time frame: 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 outcomes

  1. Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment

    Time frame: Baseline and final assessment (up to 12 Months)

    Reported data are changes in SBP from baseline at final assessment (up to 12 months).

  2. Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment

    Time frame: Baseline and final assessment (up to 12 Months)

    Reported data are changes in DBP from baseline at final assessment (up to 12 months).

  3. Changes From Baseline in Pulse Rate at Final Assessment

    Time frame: Baseline and final assessment (up to 12 Months)

    Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).

  4. Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 21, 2014
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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