Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension
1 other identifier
interventional
2,500
2 countries
232
Brief Summary
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started May 2008
Typical duration for phase_3 hypertension
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
September 1, 2010
CompletedJanuary 9, 2019
August 1, 2010
11 months
March 28, 2008
August 9, 2010
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
baseline to 12 weeks
Secondary Outcomes (3)
Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks
Baseline to 12 weeks
Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination
Baseline to 12 weeks or early termination
Change in Seated Systolic Blood Pressure From Baseline to Week 12
Baseline to week 12
Study Arms (4)
OM40/AML10
EXPERIMENTALolmesartan medoxomil 40mg and amlodipine 10mg
OM40/HCTZ25
ACTIVE COMPARATORolmesartan medoxomil 40mg and hydrochlorothiazide 25mg
AML10/HCTZ25
ACTIVE COMPARATORamlodipine 10mg and hydrochlorothiazide 25mg
OM40/AML10/HCTZ25
ACTIVE COMPARATORolmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Interventions
40mg olmesartan medoxomil
Eligibility Criteria
You may qualify if:
- Demonstrable hypertension defined as mean sitting trough cuff blood pressure ≥ 140/100 mmHg (SeSBP ≥ 140 mmHg and SeDBP ≥ 100mmHg) or mean sitting trough cuff BP ≥ 160/90 mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 90mmHg).
- Male or female newly diagnosed hypertensive subjects or currently on hypertension medication.
- Negative urine pregnancy test at screening
- Not lactating
- Do not plan to become pregnant during the study
- Will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide
- Non childbearing potential must be classified by one of the following criteria
- Had a hysterectomy or tubal ligation at least 6 months prior to consent
- Has been postmenopausal for a least 1 year
You may not qualify if:
- Mean sitting trough cuff DBP \<90 mmHg or mean sitting trough cuff SBP \<140 mmHg (off antihypertensive medication).
- Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
- Signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion.
- History of hypertensive encephalopathy, stroke or transient ischemic attack (TIA).
- Participation in another clinical trial involving an investigational drug within one month prior to screening.
- History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina within the past 6 months.
- History of secondary hypertension including renal disease, pheochromocytoma, or Cushing's syndrome.
- Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney.
- Evidence of symptomatic resting bradycardia.
- Evidence of hemodynamically significant cardiac valvular disease.
- Presence of heart block greater than first degree atrioventricular block, chronic atrial fibrillation or flutter.
- Uncontrolled Type I or Type II diabetes defined as HbA1c \>9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit. Undocumented subjects must have their HbA1c assessed prior to randomization. Note: Subjects with Type I or Type II diabetes controlled with insulin, diet or oral hypoglycemic agents on a stable dose for at least 30 days may be included.
- Evidence of liver disease as indicated by ALT and AST and/or total bilirubin \>3 times the upper limit of normal.
- Severe renal insufficiency defined as a creatinine clearance (based on the Cockcroft-Gault formula) of \<30 mL/min.
- Clinically significant laboratory elevations at Visit 1 that compromise subject safety, based on the investigator's judgment. Consideration should take into account the potential laboratory effects of the component blinded therapies.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (232)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Gulf Shores, Alabama, United States
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Hoover, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Muscle Shoals, Alabama, United States
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Tuscumbia, Alabama, United States
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Chandler, Arizona, United States
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Goodyear, Arizona, United States
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Lake Havasu City, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Buena Park, California, United States
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Burbank, California, United States
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Carmichael, California, United States
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Chino, California, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Greenbrae, California, United States
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Hollywood, California, United States
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Huntington Park, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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Merced, California, United States
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National City, California, United States
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Orange, California, United States
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Roseville, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Temecula, California, United States
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West Palm Beach, California, United States
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Westlake Village, California, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Pueblo, Colorado, United States
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Wheat Ridge, Colorado, United States
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Danbury, Connecticut, United States
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Milford, Connecticut, United States
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Stamford, Connecticut, United States
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Trumbull, Connecticut, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Crystal River, Florida, United States
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Daytona Beach, Florida, United States
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Deerfield Beach, Florida, United States
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DeLand, Florida, United States
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Delray Beach, Florida, United States
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Dunnellon, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Largo, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Bradenton, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Savannah, Georgia, United States
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Suwanee, Georgia, United States
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Waycross, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Libertyville, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Newton, Kansas, United States
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Shawnee Mission, Kansas, United States
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Wichita, Kansas, United States
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Madisonville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Munfordville, Kentucky, United States
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Paducah, Kentucky, United States
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Kenner, Louisiana, United States
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Lake Charles, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Elkridge, Maryland, United States
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Oxon Hill, Maryland, United States
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Brockton, Massachusetts, United States
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Haverhill, Massachusetts, United States
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West Yarmouth, Massachusetts, United States
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Benzonia, Michigan, United States
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Clarkston, Michigan, United States
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Paw Paw, Michigan, United States
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Southfield, Michigan, United States
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Traverse City, Michigan, United States
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Waterford, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Chaska, Minnesota, United States
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Saint Paul, Minnesota, United States
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Olive Branch, Mississippi, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Missoula, Montana, United States
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Broken Bow, Nebraska, United States
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North Platte, Nebraska, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Elizabeth, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Buffalo, New York, United States
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Manlius, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Westfield, New York, United States
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Calabash, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Tabor City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Austintown, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Euclid, Ohio, United States
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Franklin, Ohio, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Mount Gilead, Ohio, United States
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Wadsworth, Ohio, United States
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Westlake, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Harleysville, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Penndel, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Cranston, Rhode Island, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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Orangeburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Bristol, Tennessee, United States
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Fayetteville, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Tullahoma, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Lake Jackson, Texas, United States
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Midland, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Sugar Land, Texas, United States
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Temple, Texas, United States
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Waco, Texas, United States
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Bountiful, Utah, United States
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Magna, Utah, United States
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Midvale, Utah, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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Saratoga Springs, Utah, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Federal Way, Washington, United States
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Lakewood, Washington, United States
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Tacoma, Washington, United States
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Kenosha, Wisconsin, United States
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Madison, Wisconsin, United States
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Ciales, Puerto Rico
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Guayama, Puerto Rico
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Ponce, Puerto Rico
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Rio Piedras, Puerto Rico
Related Publications (4)
Kereiakes DJ, Chrysant SG, Izzo JL Jr, Littlejohn T 3rd, Melino M, Lee J, Fernandez V, Heyrman R. Olmesartan/amlodipine/hydrochlorothiazide in participants with hypertension and diabetes, chronic kidney disease, or chronic cardiovascular disease: a subanalysis of the multicenter, randomized, double-blind, parallel-group TRINITY study. Cardiovasc Diabetol. 2012 Oct 30;11:134. doi: 10.1186/1475-2840-11-134.
PMID: 23110471DERIVEDChrysant SG, Littlejohn T 3rd, Izzo JL Jr, Kereiakes DJ, Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Triple-Combination therapy with olmesartan, amlodipine, and hydrochlorothiazide in black and non-black study participants with hypertension: the TRINITY randomized, double-blind, 12-week, parallel-group study. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):233-43. doi: 10.1007/BF03261832.
PMID: 22799613DERIVEDOparil S, Melino M, Lee J, Fernandez V, Heyrman R. Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study. Clin Ther. 2010 Jul;32(7):1252-69. doi: 10.1016/j.clinthera.2010.07.008.
PMID: 20678674DERIVEDChrysant SG, Oparil S, Melino M, Karki S, Lee J, Heyrman R. Efficacy and safety of long-term treatment with the combination of amlodipine besylate and olmesartan medoxomil in patients with hypertension. J Clin Hypertens (Greenwich). 2009 Sep;11(9):475-82. doi: 10.1111/j.1751-7176.2009.00159.x.
PMID: 19751459DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Howard Kessler
- Organization
- Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2009
Study Completion
December 1, 2009
Last Updated
January 9, 2019
Results First Posted
September 1, 2010
Record last verified: 2010-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/