Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

NCT02100319 | Completed Results

• 2 other identifiers: 279-012JapicCTI-142466
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice

Conditions

Hypertension

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

• Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution

  Reported data were changes from baseline in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) measured at the medical institution.

  From baseline up to final assessment point (up to Week 24)

• Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)

  Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.

  From baseline up to final assessment point (up to Week 24)

Secondary Outcomes (4)

• Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution

  From baseline up to final assessment point (up to Week 24)

• Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution

  From baseline up to final assessment point (up to Week 24)

• Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution

  From baseline up to final assessment point (up to Week 24)

• Percentage of Participants Who Had One or More Adverse Events

  Up to Week 24

Study Arms (1)

Azilsartan at a dose of 20 to 40 mg, orally, once daily

Azilsartan tablets

Drug: Azilsartan

Interventions

Azilsartan DRUG

Azilsartan tablets

Also known as: Azilva Tablets

Azilsartan at a dose of 20 to 40 mg, orally, once daily

Eligibility Criteria

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

Study Population

Hypertension

You may qualify if:

• Patients with hypertension who meet all the following criteria will be enrolled:
• Patients who has complications of diabetes mellitus
• Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1\* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
• Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
• Patients who is an outpatient
• Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.
• \*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).

You may not qualify if:

• Patients with contraindications to azilsartan

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

azilsartan

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 6, 2014
• First Posted: March 31, 2014
• Study Start: March 3, 2014
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)