Phase 4
Completed N=380
Azilsartan Medoxomil in the Treatment of Essential Hypertension and Type 2 Diabetes in Asia
Source: ClinicalTrials.gov NCT02517866 ↗Enrolled (actual)
380
Serious AEs
1.1%
Results posted
Mar 2019
Primary outcomePrimary: 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 — 59.8; 65.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
59.8; 65.9 | — |
| SECONDARY Percentage of "Treatment-Naïve" Participants Reaching BP <140/85 mmHg |
0.0 | — |
| SECONDARY Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg |
57.8; 52.3 | — |
| SECONDARY Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg |
63.7; 63.7 | — |
| SECONDARY Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg |
79.3; 86.2 | — |
| SECONDARY Percentage of "Treatment-Naïve" Participants Reaching BP <130/80 mmHg |
0.0 | — |
| SECONDARY Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg |
26.6; 27.5 | — |
| SECONDARY Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg |
31.1; 35.2 | — |
| SECONDARY Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg |
41.4; 51.7 | — |
| SECONDARY Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12 |
68.8; 70.6; 0.0 | — |
| SECONDARY Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12 |
74.6; 81.2; 0.0 | — |
| SECONDARY Percentage of Participants With DBP <90 mmHg at Week 12 |
87.3; 87.1; 0.0 | — |
| SECONDARY Percentage of Participants With BP <130/80 mmHg at Week 12 |
33.7; 40.0; 0.0 | — |
| SECONDARY Percentage of Participants With SBP <130 mmHg at Week 12 |
41.3; 43.5; 0.0 | — |
| SECONDARY Percentage of Participants With DBP <80 mmHg at Week 12 |
57.6; 65.9; 0.0 | — |
| SECONDARY Percentage of Participants With BP <140/90 mmHg at Week 12 |
65.9; 68.2; 0.0 | — |
| SECONDARY Change From Baseline in Trough Sitting SBP at Week 12 |
-14.1; -13.3 | — |
| SECONDARY Change From Baseline in Trough Sitting SBP at Week 12 in "Treatment-Naïve" Participants |
-7 | — |
| SECONDARY Change From Baseline in DBP at Week 12 |
-4.9; -5.7 | — |
| SECONDARY Change From Baseline in DBP at Week 12 in "Treatment-Naïve" Participants |
20 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
- Have a history of alcohol abuse, drug abuse or illegal drug addiction within the 6 months prior to signing the informed consent.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Data sourced from ClinicalTrials.gov (NCT02517866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.