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HypertensionPhase 3NCT00649389

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

A Phase 3 study testing Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 232 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
232 sitesin 2 countries
Study dates
May 2008to Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

232 sites in 2 countries.

232 sites in 2 countries

United States228 sites

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Austintown, Ohio

  • Study site

    Aventura, Florida

  • Study site

    Baltimore, Maryland

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bedford, Texas

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Benzonia, Michigan

  • Study site

    Berlin, New Jersey

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brockton, Massachusetts

  • Study site

    Broken Bow, Nebraska

  • Study site

    Brooklyn Center, Minnesota

  • Study site

    Brooksville, Florida

  • Study site

    Buena Park, California

  • Study site

    Buffalo, New York

  • Study site

    Burbank, California

  • Study site

    Butte, Montana

  • Study site

    Calabash, North Carolina

  • Study site

    Cape Coral, Florida

  • Study site

    Carmichael, California

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chaska, Minnesota

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarkston, Michigan

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbiana, Alabama

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Coral Gables, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Cranston, Rhode Island

  • Study site

    Crystal River, Florida

  • Study site

    Danbury, Connecticut

  • Study site

    Daytona Beach, Florida

  • Study site

    Deerfield Beach, Florida

  • Study site

    DeLand, Florida

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Downingtown, Pennsylvania

  • Study site

    Dunnellon, Florida

  • Study site

    Durham, North Carolina

  • Study site

    East Providence, Rhode Island

  • Study site

    Elizabeth, New Jersey

  • Study site

    Elkridge, Maryland

  • Study site

    Erie, Pennsylvania

  • Study site

    Escondido, California

  • Study site

    Euclid, Ohio

  • Study site

    Eugene, Oregon

  • Study site

    Evansville, Indiana

  • Study site

    Fargo, North Dakota

  • Study site

    Fayetteville, Tennessee

  • Study site

    Federal Way, Washington

  • Study site

    Florissant, Missouri

  • Study site

    Fort Myers, Florida

  • Study site

    Franklin, Ohio

  • Study site

    Golden, Colorado

  • Study site

    Goodyear, Arizona

  • Study site

    Greenbrae, California

  • Study site

    Gulf Shores, Alabama

  • Study site

    Gurnee, Illinois

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Haverhill, Massachusetts

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Hollywood, California

  • Study site

    Hollywood, Florida

  • Study site

    Hoover, Alabama

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Huntington Park, California

  • Study site

    Huntsville, Alabama

  • Study site

    Hurst, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Jersey Shore, Pennsylvania

  • Study site

    Jonesboro, Arkansas

  • Study site

    Jupiter, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Kenner, Louisiana

  • Study site

    Kenosha, Wisconsin

  • Study site

    Kettering, Ohio

  • Study site

    Kissimmee, Florida

  • Study site

    Knoxville, Tennessee

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lake Havasu City, Arizona

  • Study site

    Lake Jackson, Texas

  • Study site

    Lakewood, Washington

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Libertyville, Illinois

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Lyndhurst, Ohio

  • Study site

    Madison, Wisconsin

  • Study site

    Madisonville, Kentucky

  • Study site

    Magna, Utah

  • Study site

    Manlius, New York

  • Study site

    Marion, Ohio

  • Study site

    Medford, Oregon

  • Study site

    Memphis, Tennessee

  • Study site

    Merced, California

  • Study site

    Merritt Island, Florida

  • Study site

    Mesa, Arizona

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Midland, Texas

  • Study site

    Midvale, Utah

  • Study site

    Milford, Connecticut

  • Study site

    Mineola, New York

  • Study site

    Missoula, Montana

  • Study site

    Mobile, Alabama

  • Study site

    Montgomery, Alabama

  • Study site

    Mount Gilead, Ohio

  • Study site

    Mount Sterling, Kentucky

  • Study site

    Munfordville, Kentucky

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nashville, Tennessee

  • Study site

    National City, California

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    New Tazewell, Tennessee

  • Study site

    New York, New York

  • Study site

    Newton, Kansas

  • Study site

    Norfolk, Virginia

  • Study site

    Norman, Oklahoma

  • Study site

    North Little Rock, Arkansas

  • Study site

    North Platte, Nebraska

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orange, California

  • Study site

    Orangeburg, South Carolina

  • Study site

    Oxon Hill, Maryland

  • Study site

    Paducah, Kentucky

  • Study site

    Palm Harbor, Florida

  • Study site

    Paw Paw, Michigan

  • Study site

    Pembroke Pines, Florida

  • Study site

    Penndel, Pennsylvania

  • Study site

    Peoria, Arizona

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Plantation, Florida

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Providence, Rhode Island

  • Study site

    Pueblo, Colorado

  • Study site

    Raleigh, North Carolina

  • Study site

    Rapid City, South Dakota

  • Study site

    Richmond, Virginia

  • Study site

    Roseville, California

  • Study site

    Round Rock, Texas

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Jose, California

  • Study site

    Sandy City, Utah

  • Study site

    Santa Ana, California

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Saratoga Springs, Utah

  • Study site

    Savannah, Georgia

  • Study site

    Scottsdale, Arizona

  • Study site

    Searcy, Arkansas

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Shreveport, Louisiana

  • Study site

    South Miami, Florida

  • Study site

    Southfield, Michigan

  • Study site

    Spring, Texas

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stamford, Connecticut

  • Study site

    Statesville, North Carolina

  • Study site

    Suffolk, Virginia

  • Study site

    Sugar Land, Texas

  • Study site

    Suwanee, Georgia

  • Study site

    Tabor City, North Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Temecula, California

  • Study site

    Temple, Texas

  • Study site

    Traverse City, Michigan

  • Study site

    Trumbull, Connecticut

  • Study site

    Tucson, Arizona

  • Study site

    Tullahoma, Tennessee

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tuscumbia, Alabama

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Waco, Texas

  • Study site

    Wadsworth, Ohio

  • Study site

    Waterbury, Connecticut

  • Study site

    Waterford, Michigan

  • Study site

    Waycross, Georgia

  • Study site

    West Bradenton, Florida

  • Study site

    West Jordan, Utah

  • Study site

    West Palm Beach, California

  • Study site

    West Yarmouth, Massachusetts

  • Study site

    Westfield, New York

  • Study site

    Westlake, Ohio

  • Study site

    Westlake Village, California

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Puerto Rico4 sites

  • Study site

    Ciales

  • Study site

    Guayama

  • Study site

    Ponce

  • Study site

    Rio Piedras

Other trials in Puerto Rico

About this study

Official title: 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

To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.

Conditions
Hypertension
Being tested
Olmesartan medoxomil, Amlodipine, Hydrochlorothiazide
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olmesartan medoxomilDrug

    Also called Benicar

    40mg olmesartan medoxomil

  • AmlodipineDrug

    Also called Norvasc

    Amlodipine 10mg

  • HydrochlorothiazideDrug

    Hydrochlorothiazide 25mg

Study groups in NCT00649389
Study groupRoleWhat they receive
OM40/AML10Experimentalolmesartan medoxomil 40mg and amlodipine 10mg
Receives: Drug: Olmesartan medoxomil; Drug: Amlodipine
OM40/HCTZ25Active comparatorolmesartan medoxomil 40mg and hydrochlorothiazide 25mg
Receives: Drug: Olmesartan medoxomil; Drug: Hydrochlorothiazide
AML10/HCTZ25Active comparatoramlodipine 10mg and hydrochlorothiazide 25mg
Receives: Drug: Amlodipine; Drug: Hydrochlorothiazide
OM40/AML10/HCTZ25Active comparatorolmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Receives: Drug: Olmesartan medoxomil; Drug: Amlodipine; Drug: Hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).

    Measured: baseline to 12 weeks

Secondary outcomes (3)

  1. 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

    Measured: Baseline to 12 weeks

  2. Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination

    Measured: Baseline to 12 weeks or early termination

  3. Change in Seated Systolic Blood Pressure From Baseline to Week 12

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00649389
Sponsor's protocol ID
CS8635-A-U301
Status last verified
Aug 2010
First submitted
28 Mar 2008
Last updated
9 Jan 2019
Data monitoring committee
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 23110471

  • 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.

    PubMed 22799613

  • 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.

    PubMed 20678674

  • 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.

    PubMed 19751459

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide in people with Hypertension, run by Daiichi Sankyo at 232 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00649389, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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