An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00412932
• Lead Sponsor: Daiichi Sankyo

Brief Summary

This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-28
• Results First Submitted QC: 2009-08-05
• Status Verified: 2009-09
• Results First Posted: 2009-09-11
• Last Update Submitted: 2009-09-15
• Last Update Posted: 2009-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

1. Males or Females greater than 65 years of age
2. Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
3. The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg.
4. Patients with a mean daytime (8am-4pm) systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than or equal to 199 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.

Exclusion Criteria

1. History of stroke or transient ischemic attack (TIA) within the last one year.
2. History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
3. Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg).
4. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome.
5. Type I diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
8. Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.
Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.	baseline to 12 weeks	All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.