A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension
1 other identifier
interventional
278
1 country
29
Brief Summary
This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. 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 Dec 2006
Shorter than P25 for phase_4 hypertension
29 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
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
January 22, 2010
CompletedOctober 2, 2018
September 1, 2018
10 months
February 1, 2007
October 3, 2008
September 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.
baseline to 12 weeks
Secondary Outcomes (9)
Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
Baseline to week 12
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
Baseline to 12 weeks
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
Baseline to 12 weeks
- +4 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALOlmesartan medoxomil, plus hydrochlorothiazide, if necessary
Placebo
PLACEBO COMPARATORPlacebo tablets were taken once daily for 12 weeks
Interventions
olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- Greater than or equal to 18 years of age.
- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 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) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg 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 (greater than or equal to 1 year), 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, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
- Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.
- Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose \<160 mg/dl may enroll.
- Patients with hemodynamically significant cardiac valvular disease.
- Patients with clinically significant cardiac conduction defects, including first, second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (29)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Deerfield Beach, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Elizabeth, New Jersey, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Eugene, Oregon, United States
Unknown Facility
Downingtown, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
New Tazewell, Tennessee, United States
Unknown Facility
Colleyville, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Murray, Utah, United States
Unknown Facility
Manassas, Virginia, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
Related Publications (2)
Kereiakes DJ, Maa JF, Shojaee A, Dubiel R. Effect of an olmesartan medoxomil-based treatment algorithm on systolic blood pressure in patients with stage 1 or 2 hypertension: a randomized, double-blind, placebo-controlled study. Am J Cardiovasc Drugs. 2010;10(4):239-46. doi: 10.2165/11538630-000000000-00000.
PMID: 20653330RESULTOparil S, Chrysant SG, Kereiakes D, Xu J, Chavanu KJ, Waverczak W, Dubiel R. Results of an olmesartan medoxomil-based treatment regimen in hypertensive patients. J Clin Hypertens (Greenwich). 2008 Dec;10(12):911-21. doi: 10.1111/j.1751-7176.2008.00045.x.
PMID: 19120717RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- 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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Study Start
December 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
October 2, 2018
Results First Posted
January 22, 2010
Record last verified: 2018-09