Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia

NCT02517866 | Completed Phase 4 Results

• 2 other identifiers: AZI-P4-002U1111-1156-8501
• Study Type: interventional
• Target: 380
• Locations: 3 countries
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.

Conditions

Essential Hypertension; Type 2 Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12

  Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.

  Week 12

Secondary Outcomes (19)

• Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg

  Up to Week 12

• Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg

  Weeks 6 and 12

• Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg

  Weeks 6 and 12

• Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg

  Weeks 6 and 12

• Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg

  Up to Week 12

Study Arms (1)

Azilsartan medoxomil

EXPERIMENTAL

Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6.

Drug: Azilsartan Medoxomil

Interventions

Azilsartan Medoxomil DRUG

Azilsartan medoxomil tablets

Also known as: Edarbi®

Azilsartan medoxomil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has type 2 diabetes mellitus (T2DM) with essential hypertension.
• T2DM participants are either treated by stable life style intervention or by oral antidiabetic drugs (OADs) that are stable, including no dose adjustment within 12 weeks before baseline.
• Is male or female and aged 18 to 75 years, inclusive.
• Uncontrolled hypertension (systolic blood pressure ≥140 mmHg to \<180 mmHg, or diastolic blood pressure ≥85 mmHg and \<110 mmHg at screening and baseline.
• Has screening glycosylated hemoglobin (HbA1C) \<9.5%.
• Female participants must be either of non-childbearing potential, ie, surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year after the last menstrual period; or, if of childbearing potential and participant is sexually active with a nonsterilized male partner, must agree to use routinely adequate contraception from signing of informed consent throughout the duration of study.

You may not qualify if:

• Has systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite concurrent treatment with three antihypertensive medications from different classes at adequate doses including a diuretic.
• Has type 1 or poorly controlled type 2 diabetes mellitus, defined as HbA1c ≥9.5% at screening.
• Is treated with OADs has not been on stable treatment including no dose change of their OADs for at least 12 weeks prior to baseline.
• Has been previously treated with azilsartan medoxomil (AZM) or azilsartan.
• Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
• Has congestive heart failure (New York Heart Association class III or IV), clinically relevant cardiac arrhythmias (as determined by the investigator's clinical judgment on a participant-by-participant basis), severe obstructive coronary artery disease.
• Has participated in a clinical trial including interventional and observational studies, or received any investigational compound currently or 30 days prior to screening.
• Has severe renal impairment (based on estimated glomerular filtration rate \[GFR\] \<30 mL/min/1.73m\^2) at Screening.
• Has hyperkalemia defined as serum potassium \>5.0 mEq/L.
• Has an alanine aminotransferase (ALT) level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at screening.
• Has any clinically relevant disease (eg malignancy, neurological, hepatic abnormalities) and/or significant abnormal laboratory findings (past or present), which, in the opinion of the investigator, may put the participant at risk because of participation in the study.
• Is taking prohibited medications including lithium and aliskiren (refer to Edarbi® product insert).
• Has known hypersensitivity to any excipients or angiotensin converting enzyme inhibitor (ACEIs)/ angiotensin receptor blockers (ARBs).
• Has prior angioedema due to an ACE inhibitor or ARB.
• Breast feeding or pregnant women or women who are intending to become pregnant before, during or within 1 month after participating in the study; or intending to donate ova during such time period, or refusal to submit to a urine test to rule out pregnancy prior to enrolment and at end of study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

Unknown Facility

Hong Kong, Hong Kong, China

Location

Unknown Facility

Changhua County, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Khon Kaen, Thailand

Location

Unknown Facility

Pathum Thani, Thailand

Location

MeSH Terms

Conditions

Essential Hypertension; Diabetes Mellitus, Type 2

Interventions

azilsartan medoxomil; azilsartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: August 7, 2015
• Study Start: July 13, 2015
• Primary Completion: November 15, 2016
• Study Completion: November 25, 2016
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2018-10

Locations

TH (4); CN (1); TW (6)