Phase 3
Completed N=362
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Source: ClinicalTrials.gov NCT00695955 ↗Enrolled (actual)
362
Serious AEs
7.8%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. — 267; 73.8 participants
Summary
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. |
267; 73.8 | — |
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. |
241; 78.5 | — |
| SECONDARY Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. |
-10.1; -13.1; -21.5; -25.4; -26.3; -27.3 | — |
| SECONDARY Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2 |
-14.4; -17.5; -23.8; -26.2; -24.8; -22.5 | — |
| SECONDARY Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1. |
-8.9; -11.0; -15.9; -18.7; -18.6; -19.9 | — |
| SECONDARY Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2. |
-10.6; -12.3; -16.8; -18.2; -17.7; -16.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
- Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.
Exclusion Criteria
- Systolic blood pressure greater than 185 mm Hg.
- Expected to take angiotensin II receptor blockers other than the study drug.
- Taking more than 2 antihypertensive agents.
- Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
- Recent history of major cardiovascular event.
- History of moderate to severe heart failure or hypertensive encephalopathy.
- Clinically significant cardiac conduction defects.
- Secondary hypertension of any etiology.
- Known or suspected unilateral or bilateral renal artery stenosis.
- Severe renal dysfunction or disease.
- History of drug abuse or a history of alcohol abuse within the past 2 years.
- Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug..
- Uncontrolled diabetes mellitus.
- Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Serum potassium level of greater than the upper limit of normal.
- Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment.
- Any other serious disease or condition.
- Randomized in a previous azilsartan medoxomil study.
Data sourced from ClinicalTrials.gov (NCT00695955). 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.