Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
NCT ID: NCT00649389
Last Updated: 2019-01-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2500 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
NCT00923091
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
NCT00654745
Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
NCT00185133
Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy
NCT01838850
Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension
NCT00902538
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OM40/AML10
olmesartan medoxomil 40mg and amlodipine 10mg
Olmesartan medoxomil
40mg olmesartan medoxomil
Amlodipine
Amlodipine 10mg
OM40/HCTZ25
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
Olmesartan medoxomil
40mg olmesartan medoxomil
Hydrochlorothiazide
Hydrochlorothiazide 25mg
AML10/HCTZ25
amlodipine 10mg and hydrochlorothiazide 25mg
Amlodipine
Amlodipine 10mg
Hydrochlorothiazide
Hydrochlorothiazide 25mg
OM40/AML10/HCTZ25
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Olmesartan medoxomil
40mg olmesartan medoxomil
Amlodipine
Amlodipine 10mg
Hydrochlorothiazide
Hydrochlorothiazide 25mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olmesartan medoxomil
40mg olmesartan medoxomil
Amlodipine
Amlodipine 10mg
Hydrochlorothiazide
Hydrochlorothiazide 25mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* Any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the investigator.
* 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.
* Positive for any one of the following tests: hepatitis B surface antigen, hepatitis C antibody (confirmed by radio immunobinding assay, RIBA) or HIV antibody (confirmed by western blot assay).
* Subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin.
* Known allergy to any of the medications used in the study.
* Subjects who require or are taking any concomitant medication, which may interfere with the objectives of the study (Refer to Section 5.2 for a listing of excluded medications).
* Pregnant or lactating females.
* Current history of drug or alcohol abuse.
* A subject with any medical condition, which in the judgment of the Investigator would jeopardize the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daiichi Sankyo Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Columbiana, Alabama, United States
Gulf Shores, Alabama, United States
Hoover, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Muscle Shoals, Alabama, United States
Tuscumbia, Alabama, United States
Chandler, Arizona, United States
Goodyear, Arizona, United States
Lake Havasu City, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
Searcy, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
Buena Park, California, United States
Burbank, California, United States
Carmichael, California, United States
Chino, California, United States
Chula Vista, California, United States
Escondido, California, United States
Greenbrae, California, United States
Hollywood, California, United States
Huntington Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Merced, California, United States
National City, California, United States
Orange, California, United States
Roseville, California, United States
San Diego, California, United States
San Jose, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Temecula, California, United States
West Palm Beach, California, United States
Westlake Village, California, United States
Denver, Colorado, United States
Golden, Colorado, United States
Pueblo, Colorado, United States
Wheat Ridge, Colorado, United States
Danbury, Connecticut, United States
Milford, Connecticut, United States
Stamford, Connecticut, United States
Trumbull, Connecticut, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
Boynton Beach, Florida, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Crystal River, Florida, United States
Daytona Beach, Florida, United States
Deerfield Beach, Florida, United States
DeLand, Florida, United States
Delray Beach, Florida, United States
Dunnellon, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Largo, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Bradenton, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
Suwanee, Georgia, United States
Waycross, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Libertyville, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Shawnee Mission, Kansas, United States
Wichita, Kansas, United States
Madisonville, Kentucky, United States
Mount Sterling, Kentucky, United States
Munfordville, Kentucky, United States
Paducah, Kentucky, United States
Kenner, Louisiana, United States
Lake Charles, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Elkridge, Maryland, United States
Oxon Hill, Maryland, United States
Brockton, Massachusetts, United States
Haverhill, Massachusetts, United States
West Yarmouth, Massachusetts, United States
Benzonia, Michigan, United States
Clarkston, Michigan, United States
Paw Paw, Michigan, United States
Southfield, Michigan, United States
Traverse City, Michigan, United States
Waterford, Michigan, United States
Brooklyn Center, Minnesota, United States
Chaska, Minnesota, United States
Saint Paul, Minnesota, United States
Olive Branch, Mississippi, United States
Florissant, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Missoula, Montana, United States
Broken Bow, Nebraska, United States
North Platte, Nebraska, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Elizabeth, New Jersey, United States
Voorhees Township, New Jersey, United States
Buffalo, New York, United States
Manlius, New York, United States
Mineola, New York, United States
New York, New York, United States
Westfield, New York, United States
Calabash, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Tabor City, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Austintown, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Euclid, Ohio, United States
Franklin, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Mount Gilead, Ohio, United States
Wadsworth, Ohio, United States
Westlake, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Downingtown, Pennsylvania, United States
Erie, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Penndel, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Cranston, Rhode Island, United States
East Providence, Rhode Island, United States
Providence, Rhode Island, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Murrells Inlet, South Carolina, United States
Orangeburg, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Fayetteville, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
New Tazewell, Tennessee, United States
Tullahoma, Tennessee, United States
Austin, Texas, United States
Bedford, Texas, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
Lake Jackson, Texas, United States
Midland, Texas, United States
Plano, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Spring, Texas, United States
Sugar Land, Texas, United States
Temple, Texas, United States
Waco, Texas, United States
Bountiful, Utah, United States
Magna, Utah, United States
Midvale, Utah, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Saratoga Springs, Utah, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Federal Way, Washington, United States
Lakewood, Washington, United States
Tacoma, Washington, United States
Kenosha, Wisconsin, United States
Madison, Wisconsin, United States
Ciales, , Puerto Rico
Guayama, , Puerto Rico
Ponce, , Puerto Rico
Rio Piedras, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Chrysant 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.
Oparil 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.
Chrysant 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS8635-A-U301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.