Clinical trial NCT00430638: A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Angiotensin Converting Enzyme Inhibitor
Hydrochlorothiazide
Stage I and II Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

* First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
* Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
* Subjects with a mean BP of \<120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
* Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
* Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
timeFrame: baseline to 12 weeks
measure: 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.
timeFrame: Baseline to week 12
measure: 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.
timeFrame: Baseline to week 12
measure: 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.
timeFrame: Baseline to 12 weeks
measure: 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.
timeFrame: Baseline to 12 weeks
measure: 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 Black Participants.
timeFrame: Baseline to week 12
measure: 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 Non-Black Participants.
timeFrame: Baseline to 12 weeks
measure: 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 Stage 1 Hypertensives
timeFrame: Baseline to 12 weeks
measure: 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 Stage 2 Hypertensives
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Searcy
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Elizabeth
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Downingtown
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Colleyville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Manassas
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
References:
citation: 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.
citation: Oparil 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.