An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes
A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension
1 other identifier
interventional
192
1 country
27
Brief Summary
This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Nov 2006
Shorter than P25 for phase_4 hypertension
27 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
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 22, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
September 15, 2009
CompletedNovember 3, 2016
September 1, 2016
1 year
November 22, 2006
November 21, 2008
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Secondary Outcomes (8)
Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
baseline and 12 weeks
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
baseline and 12 weeks
- +3 more secondary outcomes
Study Arms (1)
Active treatment
EXPERIMENTALBlood 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.
Interventions
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
- 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
You may not qualify if:
- History of stroke or transient ischemic attack (TIA) within the last one year
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (27)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Madisonville, Kentucky, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Oxon Hill, Maryland, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Florissant, Missouri, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
New Talenwell, Tennessee, United States
Unknown Facility
New Tazewell, Tennessee, United States
Unknown Facility
Colleyville, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Richardson, Texas, United States
Unknown Facility
Murray, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Related Publications (3)
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.
PMID: 21777013DERIVEDNeutel 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.
PMID: 20712386DERIVEDNeutel 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.
PMID: 20085534DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John J. Raia, R.Ph, Pharm. D.
- Organization
- Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 22, 2006
First Posted
November 23, 2006
Study Start
November 1, 2006
Primary Completion
November 1, 2007
Study Completion
December 1, 2007
Last Updated
November 3, 2016
Results First Posted
September 15, 2009
Record last verified: 2016-09