Olmesartan Comparison to Losartan in Hypertensive Subjects
A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects
1 other identifier
interventional
941
1 country
20
Brief Summary
This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Aug 2009
Shorter than P25 for phase_4 hypertension
20 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
First Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
February 28, 2011
CompletedMarch 9, 2011
March 1, 2011
5 months
July 29, 2009
January 31, 2011
March 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Day 0, Week 8
Secondary Outcomes (3)
Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Day 0, Week 4
Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Day 0, Week 8
Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Day 0, Week 4
Other Outcomes (11)
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
Week 4, Week 8
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
Week 4, Week 8
Percentage of Participants Achieving Blood Pressure Goals at Week 4
Week 4
- +8 more other outcomes
Study Arms (3)
Olmesartan
EXPERIMENTALOlmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Placebo followed by Olmesartan
PLACEBO COMPARATORPlacebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
Losartan
ACTIVE COMPARATORLosartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Interventions
Oral tablets, once daily, at either 20mg or 40mg daily.
losartan potassium oral tablet at either 50mg or 100 mg daily dose.
Eligibility Criteria
You may qualify if:
- Males or females aged \> 18 years who are not institutionalized and have signed informed consent.
- Mean cuff seated diastolic blood pressure (BP) must be \> 95 mmHg and \< 115 mmHg and a mean cuff seated systolic BP must be \< 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
- The difference in mean cuff seated diastolic BP must be \< 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.
You may not qualify if:
- Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
- Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c \< 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
- Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
- Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
- Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (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 (20)
Unknown Facility
Mesa, Arizona, 85213, United States
Unknown Facility
Phoenix, Arizona, 85050, United States
Unknown Facility
Harbor City, California, 90710, United States
Unknown Facility
Tustin, California, 92780, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Pueblo, Colorado, 81001, United States
Unknown Facility
Deerfield Beach, Florida, 33442, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
South Bend, Indiana, 46614, United States
Unknown Facility
Wichita, Kansas, 67205, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
Unknown Facility
Binghamton, New York, 13701, United States
Unknown Facility
Charlotte, North Carolina, 28209, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
New Tazewell, Tennessee, 37825, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Related Publications (1)
Punzi HA, Lewin A, Li W, Chavanu KJ. Efficacy/safety of olmesartan medoxomil versus losartan potassium in naive versus previously treated subjects with hypertension. Adv Ther. 2012 Jun;29(6):524-37. doi: 10.1007/s12325-012-0029-5. Epub 2012 Jul 3.
PMID: 22763801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Dubiel, PharmD
- Organization
- Daiichi Sankyo, Inc.
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
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 9, 2011
Results First Posted
February 28, 2011
Record last verified: 2011-03