An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients With Hypertension
1 other identifier
interventional
178
1 country
29
Brief Summary
This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with 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 Dec 2006
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 14, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
September 11, 2009
CompletedSeptember 22, 2009
September 1, 2009
1.3 years
December 14, 2006
April 28, 2009
September 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
baseline to 12 weeks
Secondary Outcomes (6)
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
baseline to 12 weeks
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
baseline to 12 weeks
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment
baseline to 12 weeks
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment
baseline to 12 weeks
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.
baseline to 12 weeks
- +1 more secondary outcomes
Interventions
Tablets
Tablets
Eligibility Criteria
You may qualify if:
- Males or Females greater than 65 years of age
- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
- The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x 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 140 mmHg and less than or equal to 199 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.
You may not qualify if:
- History of stroke or transient ischemic attack (TIA) within the last one year.
- History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
- Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure 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 diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
- 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, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
- Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (29)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pomona, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Farmington, Connecticut, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
New Port Richey, 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
Florissant, Missouri, United States
Unknown Facility
Berlin, New Jersey, United States
Unknown Facility
Williamsville, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Richardson, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
Related Publications (2)
Germino FW, Neutel JM, Dubiel R, Maa JF, Chavanu KJ. Efficacy of olmesartan medoxomil and hydrochlorothiazide fixed-dose combination therapy in patients aged 65 years and older with stage 1 and 2 hypertension or isolated systolic hypertension. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):325-33. doi: 10.1007/BF03261841.
PMID: 22920048DERIVEDNeutel J, Kereiakes DJ, Stoakes KA, Maa JF, Shojaee A, Waverczak WF. Blood pressure-lowering efficacy of an olmesartan medoxomil/hydrochlorothiazide-based treatment algorithm in elderly patients (age >/=65 years) stratified by age, sex and race: subgroup analysis of a 12-week, open-label, single-arm, dose-titration study. Drugs Aging. 2011 Jun 1;28(6):477-90. doi: 10.2165/11589460-000000000-00000.
PMID: 21639407DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Raia
- 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
December 14, 2006
First Posted
December 19, 2006
Study Start
December 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
September 22, 2009
Results First Posted
September 11, 2009
Record last verified: 2009-09