An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes
NCT ID: NCT00403481
Last Updated: 2016-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
192 participants
INTERVENTIONAL
2006-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active treatment
Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.
olmesartan medoxomil
Olmesartan medoxomil tablets, once daily
Olmesartan medoxomil plus Hydrochlorothiazide
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
Interventions
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olmesartan medoxomil
Olmesartan medoxomil tablets, once daily
Olmesartan medoxomil plus Hydrochlorothiazide
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
Eligibility Criteria
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Inclusion Criteria
* Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but \<200 mmHg and a MSDBP less than or equal to 114 mmHg following a 3 to 4-week single-blind placebo run-in period
* The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg
* Patients with a mean daytime (8AM - 4PM) SBP \> 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period
* If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
Exclusion Criteria
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
* Presence of overt proteinuria at screening
* Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
* Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
* Type I or Type II diabetes requiring insulin
* Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
* Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Searcy, Arkansas, United States
Los Angeles, California, United States
Roseville, California, United States
Tustin, California, United States
DeLand, Florida, United States
Pembroke Pines, Florida, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Madisonville, Kentucky, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
Oxon Hill, Maryland, United States
Jackson, Mississippi, United States
Florissant, Missouri, United States
Williamsville, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
New Talenwell, Tennessee, United States
New Tazewell, Tennessee, United States
Colleyville, Texas, United States
Corpus Christi, Texas, United States
Richardson, Texas, United States
Murray, Utah, United States
Norfolk, Virginia, United States
Countries
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References
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Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus. Drugs R D. 2011 Sep 1;11(3):251-7. doi: 10.2165/11592830-000000000-00000.
Neutel JM, Kereiakes DJ; BENIFICIARY Investigators. An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study. Am J Cardiovasc Drugs. 2010;10(5):289-303. doi: 10.2165/11584690-000000000-00000.
Neutel JM, Kereiakes DJ, Waverczak WF, Stoakes KA, Xu J, Shojaee A. Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes. Curr Med Res Opin. 2010 Mar;26(3):721-8. doi: 10.1185/03007990903553556.
Other Identifiers
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866-449
Identifier Type: -
Identifier Source: org_study_id