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

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ClinicalTrials.gov Identifier: NCT02068495
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hypertension 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
Actual Enrollment : 3409 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Actual Study Start Date : June 15, 2010
Actual Primary Completion Date : May 31, 2013
Actual Study Completion Date : May 31, 2013

Resource links provided by the National Library of Medicine


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 Name: Unisia Combination Tablets




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertension
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068495


Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02068495     History of Changes
Other Study ID Numbers: 119-011
JapicCTI-132390 ( Registry Identifier: JapicCTI )
First Posted: February 21, 2014    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists