A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

NCT ID: NCT00430638

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-10-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Olmesartan medoxomil, plus hydrochlorothiazide, if necessary

Group Type: EXPERIMENTAL

olmesartan medoxomil + hydrochlorothiazide, if necessary

Intervention Type: DRUG

olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks

Placebo

Placebo tablets were taken once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral tablets administered for once daily for 12 weeks

Interventions

olmesartan medoxomil + hydrochlorothiazide, if necessary

olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks

Intervention Type: DRUG

Placebo

Oral tablets administered for once daily for 12 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Mobile, Alabama, United States

Muscle Shoals, Alabama, United States

Searcy, Arkansas, United States

Carmichael, California, United States

Spring Valley, California, United States

Coral Gables, Florida, United States

Deerfield Beach, Florida, United States

DeLand, Florida, United States

Fort Lauderdale, Florida, United States

Hialeah, Florida, United States

Hollywood, Florida, United States

Pembroke Pines, Florida, United States

Chicago, Illinois, United States

Elizabeth, New Jersey, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Downingtown, Pennsylvania, United States

Charleston, South Carolina, United States

Nashville, Tennessee, United States

New Tazewell, Tennessee, United States

Colleyville, Texas, United States

San Antonio, Texas, United States

Murray, Utah, United States

Manassas, Virginia, United States

Olympia, Washington, United States

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20653330 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19120717 (View on PubMed)

Other Identifiers

866-451

Identifier Type: -

Identifier Source: org_study_id