One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00695955 |
|
Recruitment Status :
Completed
First Posted : June 12, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
|
Sponsor:
Takeda
Information provided by:
Takeda
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Azilsartan medoxomil with or without add-on chlorthalidone Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide | Phase 3 |
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. 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 antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.
Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 669 participants |
| Allocation: | Non-Randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension |
| Study Start Date : | June 2007 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | May 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
| Arm | Intervention/treatment |
|---|---|
| Experimental: Azilsartan Medoxomil |
Drug: Azilsartan medoxomil with or without add-on chlorthalidone
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Other Names:
Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
Other Names:
|
Primary Outcome Measures :
- Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. [ Time Frame: 56 weeks. ]Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
- Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2. [ Time Frame: 56 weeks. ]Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Secondary Outcome Measures :
- Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1. [ Time Frame: 52 weeks ]The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2 [ Time Frame: 52 weeks ]The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1. [ Time Frame: 52 weeks. ]The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2. [ Time Frame: 52 weeks. ]The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695955
Locations
| United States, Alabama | |
| Ozark, Alabama, United States | |
| Tallassee, Alabama, United States | |
| United States, California | |
| Long Beach, California, United States | |
| Santa Rosa, California, United States | |
| Spring Valley, California, United States | |
| United States, Colorado | |
| Colorado Springs, Colorado, United States | |
| United States, Connecticut | |
| Trumbull, Connecticut, United States | |
| Waterbury, Connecticut, United States | |
| United States, Florida | |
| Fort Lauderdale, Florida, United States | |
| Hollywood, Florida, United States | |
| Jacksonville, Florida, United States | |
| Miami, Florida, United States | |
| Pembroke Pines, Florida, United States | |
| Pinellas Park, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Augusta, Georgia, United States | |
| United States, Minnesota | |
| Brooklyn Center, Minnesota, United States | |
| United States, Mississippi | |
| Olive Branch, Mississippi, United States | |
| United States, New York | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| Salisbury, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| Mogadore, Ohio, United States | |
| Springdale, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Anderson, South Carolina, United States | |
| Mt. Pleasant, South Carolina, United States | |
| Simpsonville, South Carolina, United States | |
| United States, Tennessee | |
| Bristol, Tennessee, United States | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Arlington, Texas, United States | |
| Austin, Texas, United States | |
| North Richland Hills, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
| Chile | |
| San Bernardo, Santiago, Chile | |
| Mexico | |
| Tijuana, BC, Mexico | |
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Executive Medical Director Clinical Science | Takeda |
| Responsible Party: | Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00695955 |
| Other Study ID Numbers: |
01-05-TL-491-006 U1111-1113-8874 ( Registry Identifier: WHO ) |
| First Posted: | June 12, 2008 Key Record Dates |
| Results First Posted: | April 19, 2011 |
| Last Update Posted: | April 19, 2011 |
| Last Verified: | March 2011 |
Keywords provided by Takeda:
|
Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy |
Additional relevant MeSH terms:
|
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Chlorthalidone Azilsartan medoxomil Antihypertensive Agents |
Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |