An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00403481

Purpose

This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. 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 Hydrochlorothyazide	Phase IV

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Calcium gluconate Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change from baseline in Systolic BP (SBP) after 12 weeks of active treatment as measured by 24-hour ABPM.

Secondary Outcome Measures:

Change from baseline in mean 24-hr ABPM Diastolic BP (DBP) after 12 weeks active treatment.
Percentage of patients achieving mean 24-hr, daytime, nighttime, last 2,4,6-hr ABPM BP goals: SBP<140;<135;<130;<125;<120mmHg; DBP<90;<85;<80;<75mmHg; BP<140/90;<135/85;<130/80;<120/80 and <125/75mmHg at end of study.

Estimated Enrollment:	200
Study Start Date:	November 2006
Study Completion Date:	December 2007
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

>18 years of age
Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 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 > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 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-menapausal, 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, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Presence of overt proteinuria at screening
Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I or Type II diabetes requiring insulin
Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403481

Show 27 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo ( William Waverczak )
Study ID Numbers:	866-449
Study First Received:	November 22, 2006
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00403481
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

Hydrochlorothyazide
Stage I and II Hypertension
Type II Diabetes

Study placed in the following topic categories:

Calcium, Dietary
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus

Olmesartan medoxomil
Angiotensin II
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009