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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil
* Drug: Olmesartan medoxomil plus Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide. | Drug: olmesartan medoxomil<br>* Olmesartan medoxomil tablets, once daily<br>Drug: Olmesartan medoxomil plus Hydrochlorothiazide<br>* Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| 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. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| 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. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| 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. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic) | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 
| 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. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 Weeks | 
| 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. | Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study. | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension, Type II Diabetes