Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00362115
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.
- Detailed Description
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy.
Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated essential hypertension.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at approximately 24 and 36 hour intervals.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 449
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo QD Placebo - Azilsartan Medoxomil 5 mg QD Azilsartan Medoxomil - Azilsartan Medoxomil 10 mg QD Azilsartan Medoxomil - Azilsartan Medoxomil 20 mg QD Azilsartan Medoxomil - Azilsartan Medoxomil 80 mg QD Azilsartan Medoxomil - Olmesartan 20 mg QD Olmesartan - Azilsartan Medoxomil 40 mg QD Azilsartan Medoxomil -
- Primary Outcome Measures
Name Time Method Change From Baseline in Sitting Clinic Diastolic Blood Pressure. Baseline and Week 8. The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Sitting Clinic Systolic Blood Pressure. Baseline and Week 8 The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Change From Baseline in Standing Clinic Systolic Blood Pressure. Baseline and Week 8. The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.
Change From Baseline in Standing Clinic Diastolic Blood Pressure. Baseline and Week 8. The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.
Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.
Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.
Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8 The change in trough mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in trough mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.
Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.
Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8 The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.
Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. Baseline and Week 8. The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.