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

NCT02068495 | Completed Results

• 2 other identifiers: 119-011JapicCTI-132390
• Study Type: observational
• Target: 3,409
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  Baseline and final assessment (up to 12 Months)

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

  Baseline and final assessment (up to 12 Months)

• Changes From Baseline in Pulse Rate at Final Assessment

  Baseline and 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)

Study Arms (1)

Candesartan cilexetil/Amlodipine besilate

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

Drug: Candesartan cilexetil/Amlodipine besilate

Interventions

Candesartan cilexetil/Amlodipine besilate DRUG

Candesartan cilexetil/Amlodipine besilate tablets

Also known as: Unisia Combination Tablets

Candesartan cilexetil/Amlodipine besilate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertension

You may qualify if:

• \. Participants with hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: June 15, 2010
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share