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

NCT02211638 | Completed Results

• 3 other identifiers: 460-017JapicCTI-132380JapicCTI-R171021
• Study Type: observational
• Target: 18,113
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Changes in Clinic Blood Pressure in the Sitting Position

  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.

  Baseline, Month 3 and Last dose of Candesartan (up to Month 6)

• Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14

  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.

  Baseline, Month 3 and Last dose of Candesartan (up to Month 6)

• Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14

  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.

  Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)

• Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14

  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.

  Baseline and Last dose of ARB Combination Drug (up to Month 6)

• 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

  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.

  Baseline and Last dose of ARB Combination Drug (up to Month 6)

Secondary Outcomes (1)

• Number of Participants Who Experience at Least One Adverse Drug Reactions

  Up to Month 3

Study Arms (1)

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

Interventions

Candesartan Cilexetil DRUG

Candesartan Cilexetil tablet

Also known as: Blopress

Candesartan Cilexetil tablets (2 to 12 mg)

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

Hypertension

You may qualify if:

• Hypertensive patients

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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: March 17, 2014
• First Posted: August 7, 2014
• Study Start: June 13, 2011
• Primary Completion: April 25, 2013
• Study Completion: April 25, 2013
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)