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

Unisia 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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Candesartan cilexetil/Amlodipine besilate

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 Type: Observational
• Enrollment (Actual): 3409

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypertension

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Candesartan cilexetil/Amlodipine besilate; 8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily	Drug: Candesartan cilexetil/Amlodipine besilate; Candesartan cilexetil/Amlodipine besilate tablets; Other Names: Unisia Combination Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment	Reported data are changes in SBP from baseline at final assessment (up to 12 months).	Baseline and final assessment (up to 12 Months)
Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment	Reported data are changes in DBP from baseline at final assessment (up to 12 months).	Baseline and final assessment (up to 12 Months)
Changes From Baseline in Pulse Rate at Final Assessment	Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).	Baseline and final assessment (up to 12 Months)
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment	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.	Baseline and final assessment (up to 12 Months)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2010
• Primary Completion (Actual): May 31, 2013
• Study Completion (Actual): May 31, 2013

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: 119-011; JapicCTI-132390 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No