Clinical trial NCT00403481: An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes
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
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
Type II Diabetes
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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-menopausal, 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

Primary outcomes:
measure: Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
timeFrame: baseline and 12 weeks
measure: Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
timeFrame: baseline and 12 weeks
measure: Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
timeFrame: baseline and 12 weeks
measure: Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
timeFrame: baseline and 12 weeks
measure: Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
timeFrame: baseline and 12 weeks
measure: Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
timeFrame: baseline and 12 weeks
measure: Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
timeFrame: baseline and 12 Weeks
measure: Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Searcy
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Roseville
country: United States
state: California
city: Tustin
country: United States
state: California
city: Deland
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Madisonville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Florissant
country: United States
state: Missouri
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: New Talenwell
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Colleyville
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
References:
citation: Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus. Drugs R D. 2011 Sep 1;11(3):251-7. doi: 10.2165/11592830-000000000-00000.
citation: Neutel JM, Kereiakes DJ; BENIFICIARY Investigators. An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study. Am J Cardiovasc Drugs. 2010;10(5):289-303. doi: 10.2165/11584690-000000000-00000.
citation: Neutel JM, Kereiakes DJ, Waverczak WF, Stoakes KA, Xu J, Shojaee A. Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes. Curr Med Res Opin. 2010 Mar;26(3):721-8. doi: 10.1185/03007990903553556.