We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With 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: NCT00649389
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : September 1, 2010
Last Update Posted : January 9, 2019
Information provided by:
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil Drug: Amlodipine Drug: Hydrochlorothiazide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OM40/AML10
olmesartan medoxomil 40mg and amlodipine 10mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar

Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc

Active Comparator: OM40/HCTZ25
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar

Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg

Active Comparator: AML10/HCTZ25
amlodipine 10mg and hydrochlorothiazide 25mg
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc

Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg

Active Comparator: OM40/AML10/HCTZ25
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar

Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc

Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg

Primary Outcome Measures :
  1. Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). [ Time Frame: baseline to 12 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: Baseline to 12 weeks ]
  2. Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination [ Time Frame: Baseline to 12 weeks or early termination ]
  3. Change in Seated Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline to week 12 ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

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): NCT00649389

Show Show 232 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Executive Director Clinical Development, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00649389    
Other Study ID Numbers: CS8635-A-U301
First Posted: April 1, 2008    Key Record Dates
Results First Posted: September 1, 2010
Last Update Posted: January 9, 2019
Last Verified: August 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists