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Trial record 9 of 914 for:    tablet | Japan

Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)

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ClinicalTrials.gov Identifier: NCT02016183
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD&HD in hypertensive patients in the routine clinical setting

Condition or disease Intervention/treatment
Hypertension Drug: Candesartan cilexetil / hydrochlorothiazide

Detailed Description:

This is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD combination tablets) to evaluate in hypertensive patients in the routine clinical setting. Because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000).

The usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. This drug should not be used as a first-line drug for hypertension treatment.


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Study Type : Observational
Actual Enrollment : 3222 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECARD Combination Tablets LD&HD Special Drug Use Surveillance: Long-term Use (12 Months)
Actual Study Start Date : April 1, 2009
Actual Primary Completion Date : September 30, 2012
Actual Study Completion Date : September 30, 2012


Group/Cohort Intervention/treatment
Candesartan cilexetil / hydrochlorothiazide
Candesartan cilexetil/Hydrochlorothiazide 4 mg/6.25 mg or 8 mg/6.25 mg combination tablets, orally, once daily for up to 12 months. This drug should not be used as a first-line drug for hypertension treatment. Participants received interventions as part of routine medical care.
Drug: Candesartan cilexetil / hydrochlorothiazide
Candesartan cilexetil / hydrochlorothiazide combination tablets
Other Name: ECARD® Combination Tablets LD&HD




Primary Outcome Measures :
  1. 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 Each Time Point [ Time Frame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) ]
    Reported data are changes in SBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.

  2. Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point [ Time Frame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) ]
    Reported data are changes in DBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.

  3. Changes From Baseline in Pulse Rate at Each Time Point [ Time Frame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) ]
    Reported data are changes in Pulse Rate from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.



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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
Patients with Hypertension
Criteria

Inclusion Criteria:

  • Hypertensive patients

Exclusion Criteria:

(1) Patients with a history of hypersensitivity to ingredients of ECARD LD&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant

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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): NCT02016183


Locations
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Japan
Tokyo, 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: NCT02016183     History of Changes
Other Study ID Numbers: 220-011
JapicCTI-132362 ( Registry Identifier: JapicCTI )
First Posted: December 19, 2013    Key Record Dates
Results First Posted: November 9, 2018
Last Update Posted: November 9, 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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Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists