Clinical trial NCT02211638: Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」
Official title: Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 18113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in Clinic Blood Pressure in the Sitting Position
timeFrame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
measure: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14
timeFrame: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
measure: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14
timeFrame: Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)
measure: Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14
timeFrame: Baseline and Last dose of ARB Combination Drug (up to Month 6)
measure: 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
timeFrame: Baseline and Last dose of ARB Combination Drug (up to Month 6)
Secondary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions
timeFrame: Up to Month 3
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: