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Trial record 74 of 913 for:    tablet | Japan

Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」

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ClinicalTrials.gov Identifier: NCT02211638
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.

Condition or disease Intervention/treatment
Hypertension Drug: Candesartan Cilexetil

Detailed Description:

This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure.

The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.


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Study Type : Observational
Actual Enrollment : 18113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」
Actual Study Start Date : June 13, 2011
Actual Primary Completion Date : April 25, 2013
Actual Study Completion Date : April 25, 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Candesartan Cilexetil tablets (2 to 12 mg)
Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months
Drug: Candesartan Cilexetil
Candesartan Cilexetil tablet
Other Name: Blopress




Primary Outcome Measures :
  1. Changes in Clinic Blood Pressure in the Sitting Position [ Time Frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6) ]
    Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported.

  2. Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 [ Time Frame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6) ]
    Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported.

  3. Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 [ Time Frame: Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) ]
    Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.

  4. Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 [ Time Frame: Baseline and Last dose of ARB Combination Drug (up to Month 6) ]
    Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.

  5. Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 [ Time Frame: Baseline and Last dose of ARB Combination Drug (up to Month 6) ]
    Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.


Secondary Outcome Measures :
  1. Number of Participants Who Experience at Least One Adverse Drug Reactions [ Time Frame: Up to Month 3 ]
    Adverse drug reactions 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.



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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:

  • Hypertensive patients

Exclusion Criteria:

  1. Inpatients
  2. Patients under dialysis (planned)
  3. Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
  4. Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
  5. Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
  6. Patients who are pregnant or may possibly become pregnant

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): NCT02211638


Locations
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Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02211638     History of Changes
Other Study ID Numbers: 460-017
JapicCTI-132380 ( Registry Identifier: JapicCTI )
JapicCTI-R171021 ( Other Identifier: JapicCTI )
First Posted: August 7, 2014    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action