Phase 3
Completed N=566
Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension
Source: ClinicalTrials.gov NCT00591266 ↗Enrolled (actual)
566
Serious AEs
0.7%
Results posted
Apr 2011
Primary outcomePrimary: Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. — -24.79; -24.51; -13.60 mmHg — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-24.79; -24.51; -13.60 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. |
-26.96; -25.50; -15.94 | <0.001 sig |
| SECONDARY Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-15.26; -15.43; -7.79 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure |
-12.00; -12.65; -7.07 | <0.001 sig |
| SECONDARY Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-25.42; -24.95; -13.79 | <0.001 sig |
| SECONDARY Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-15.81; -15.86; -7.82 | <0.001 sig |
| SECONDARY Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-22.75; -22.72; -13.05 | <0.001 sig |
| SECONDARY Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-13.76; -13.78; -7.50 | <0.001 sig |
| SECONDARY Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring |
-26.10; -25.40; -13.82 | <0.001 sig |
| SECONDARY Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring |
-16.13; -15.97; -7.74 | <0.001 sig |
| SECONDARY Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-22.60; -22.67; -13.76 | <0.001 sig |
| SECONDARY Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. |
-14.34; -14.93; -8.39 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg |
72.7; 71.6; 45.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg |
86.1; 87.4; 65.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response |
65.8; 69.4; 43.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Has essential hypertension and 24-hour mean systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 180 mm Hg.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
- Has clinical laboratory evaluations within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
- Is willing to discontinue current antihypertensive medications.
Exclusion Criteria
- Has sitting trough clinic diastolic blood pressure greater than 119 mm Hg.
- Has a baseline 24 hour ambulatory blood pressure monitoring reading of insufficient quality.
- The subject is hypersensitive to angiotensin II receptor blockers or calcium channel blockers.
- Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Has clinically significant cardiac conduction defects.
- Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
- Has secondary hypertension of any etiology
- Is non-compliant with study medication during placebo run-in period.
- Has severe renal dysfunction or disease.
- Has known or suspected unilateral or bilateral renal artery stenosis.
- Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
- Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
- Has type 1 or poorly controlled type 2 diabetes mellitus.
- Has hyperkalemia as defined by the central laboratory normal reference range,
- Has an alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease or jaundice.
- Has an upper arm circumference less than 24 cm or greater than 42 cm.
- Works night (3rd) shift.
- Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
- Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
- Has been randomized in a previous TAK-491 study.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Data sourced from ClinicalTrials.gov (NCT00591266). 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.