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

NCT02016183 | Completed Results

• 2 other identifiers: 220-011JapicCTI-132362
• Study Type: observational
• Target: 3,222
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (3)

• Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point

  Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)

• Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point

  Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)

• Changes From Baseline in Pulse Rate at Each Time Point

  Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)

Study Arms (1)

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

Interventions

Candesartan cilexetil / hydrochlorothiazide DRUG

Candesartan cilexetil / hydrochlorothiazide combination tablets

Also known as: ECARD® Combination Tablets LD&HD

Candesartan cilexetil / hydrochlorothiazide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Hypertension

You may qualify if:

• Hypertensive patients

You may not qualify if:

• (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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2013
• First Posted: December 19, 2013
• Study Start: April 1, 2009
• Primary Completion: September 30, 2012
• Study Completion: September 30, 2012
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)