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

• 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: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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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Contacts and Locations

Locations

Japan

Tokyo, Japan

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Study Director; Takeda

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02016183
• Other Study ID Numbers: 220-011; JapicCTI-132362 ( Registry Identifier: JapicCTI )
• First Posted: December 19, 2013
• 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

• 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; 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