HypertensionNCT02068495

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

An observational study of Hypertension, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Candesartan cilexetil/Amlodipine besilate
Type of treatment: Pill or oral medicine
How many people: 3,409 participants
Where: No sites listed yet
Study dates: 15 Jun 2010to 31 May 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Hypertension

Who may be able to join

1. Participants with hypertension

Who cannot join

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

About this study

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

Read the 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.

Conditions: Hypertension
Being tested: Candesartan cilexetil/Amlodipine besilate
Keywords: Drug therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Candesartan cilexetil/Amlodipine besilateDrug
Also called Unisia Combination Tablets
Candesartan cilexetil/Amlodipine besilate tablets

Study groups in NCT02068495
Study group	Role	What they receive
Candesartan cilexetil/Amlodipine besilate		8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily Receives: Drug: Candesartan cilexetil/Amlodipine besilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experience at Least One Adverse Events
Measured: 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.
Measured: Up to 12 Months

Secondary outcomes (4)

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline and final assessment (up to 12 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201031 May 2013

First posted21 Feb 2014 (estimated)
Study start15 Jun 2010
Primary completion31 May 2013
Study completion31 May 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,409 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02068495
Sponsor's protocol ID: 119-011
Other IDs: JapicCTI-132390
Status last verified: Jul 2018
First submitted: 19 Feb 2014
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
ClinicalTrials.gov ID: NCT02068495
Acronym / sponsor ID: 119-011
Conditions: Hypertension
Keywords: Drug therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,409 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 15 Jun 2010 (actual)
Primary completion: 31 May 2013 (actual)
Study completion: 31 May 2013 (actual)
First posted: 21 Feb 2014 (estimated)
Results: Posted 26 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Candesartan cilexetil/Amlodipine besilate	–	Drug: Candesartan cilexetil/Amlodipine besilate8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Hypertension

Key inclusion criteria (1 listed)

1. Participants with hypertension

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Candesartan cilexetil/Amlodipine besilateAlso: Unisia Combination TabletsCandesartan cilexetil/Amlodipine besilate tablets	Drug	Candesartan cilexetil/Amlodipine besilate

Primary outcome

Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to 12 Months
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.

4 secondary outcomes

Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment
Time frame: Baseline and final assessment (up to 12 Months)
Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment
Time frame: Baseline and final assessment (up to 12 Months)
Changes From Baseline in Pulse Rate at Final Assessment
Time frame: Baseline and final assessment (up to 12 Months)
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment
Time frame: Baseline and final assessment (up to 12 Months)

Results and safety

Results posted to the registry on 26 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Candesartan Cilexetil/Amlodipine	3,409	3,300

Primary outcome: Number of Participants Who Experience at Least One Adverse Events

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Candesartan Cilexetil/Amlodipine n = 3300
Value	286

Population analysed: The safety analysis set was defined as all participants who were enrolled and completed the study.

Primary outcome: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Candesartan Cilexetil/Amlodipine n = 3300
Value	85

Population analysed: The safety analysis set was defined as all participants who were enrolled and completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 Months. Other adverse events reported at 0.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Candesartan Cilexetil/Amlodipine	63 of 3,300 (1.9%)	97 of 3,300 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience at Least One Adverse Events (time frame: Up to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02068495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.