Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension
A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension
1 other identifier
interventional
185
1 country
18
Brief Summary
This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Sep 2007
Shorter than P25 for phase_3 hypertension
18 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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 10, 2007
CompletedFirst Posted
Study publicly available on registry
September 11, 2007
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 23, 2009
CompletedNovember 11, 2009
November 1, 2009
7 months
September 10, 2007
May 5, 2009
November 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
Baseline to 12 Weeks
Secondary Outcomes (5)
Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Baseline to 12 weeks
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
Baseline to end of week 3
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
Baseline to end of week 6
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
Baseline to end of week 9
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
Baseline to end end of week 12
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Males or females greater than or equal to 18 years of age
- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
- Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
- 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 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 (18)
Unknown Facility
Buena Park, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
Castle Rock, Colorado, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Orland Park, Illinois, United States
Unknown Facility
Natick, Massachusetts, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Beaver, Pennsylvania, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Carrolton, Texas, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Madison, Wisconsin, United States
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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2007
First Posted
September 11, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 11, 2009
Results First Posted
September 23, 2009
Record last verified: 2009-11