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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00430638

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil plus Hydrochlorothyiazide	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change from baseline in mean Systolic BP (SBP) after 12 weeks of randomized treatment as measured by Omron device. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean Diastolic BP (DBP) after 12 weeks of randomized treatment as measured by Omron device. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in mean SBP and DBP at each titration step as measured by Omron device. [ Designated as safety issue: No ]
Incremental cuff BP change between each titration step. [ Designated as safety issue: No ]
The percentage of patients achieving cuff BP goals of: SBP <140, <130, <120 mmHg; DBP <9-, <85, <80 mmHg and BP <140/90, <130/85, <130/80 and <120/80 mmHg at each titration period and at end of study. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number and percentage of patients achieving DBP drop in the following categories: drop less than or equal to15 mmHg; 15 <drop less than or equal to 30 mmHg; 30 <drop less than or equal to 45 mmHg; drop > 45 mmHg. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number and percentage of patients achieving DBP drop in the following categories: drop less than or equal to 10 mmHg; 10 <drop less than or equal to 15 mmHg; 15 <drop less than or equal to 20 mmHg; drop > 20 mmHg. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subgroup analyses by age group (<65 yrs and greater than or equal to 65 yrs),race group (Black and Non-Black), gender group (Male and Female), and cuff BP stage (Stages 1 and 2), respectively, on all of the aforementioned baseline variables. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	December 2006
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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) SBP greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430638

Show 29 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Daiichi Sankyo ( William Waverczak )
Study ID Numbers:	866-451
Study First Received:	February 1, 2007
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00430638 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker

Angiotensin Converting Enzyme Inhibitor
Hydrochlorothiazide
Stage I and II Hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Vascular Diseases
Calcium Channel Blockers
Angiotensin-Converting Enzyme Inhibitors
Olmesartan medoxomil

Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Hydrochlorothiazide
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Olmesartan medoxomil
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009