Phase 4 Completed N=192 Treatment

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

Hypertension

Source: ClinicalTrials.gov NCT00403481 ↗

Enrolled (actual)

192

Serious AEs

0.1%

Results posted

Sep 2009

Primary outcomePrimary: Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. — -20.4 mm Hg — p=<0.0001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.	-20.4	<0.0001 sig
SECONDARY Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).	-22.3; -18.8	<0.0001 sig
SECONDARY 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.	-18.6	<0.0001 sig
SECONDARY 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.	-18.2	0.0001 sig
SECONDARY 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.	-18.6	—
SECONDARY Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)	-11.1	<0.0001 sig
SECONDARY Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12	-12.0; -10.2	<0.0001 sig
SECONDARY 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.	-10.6	<0.0001 sig
SECONDARY 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.	-10.7; -10.8	<0.0001 sig

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00403481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.