Clinical trial NCT00412932: An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
Official title: A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly 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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 178
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
timeFrame: baseline to 12 weeks
measure: Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
timeFrame: baseline to 12 weeks
measure: 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
timeFrame: baseline to 12 weeks
measure: 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
timeFrame: baseline to 12 weeks
measure: 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.
timeFrame: baseline to 12 weeks
measure: 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.
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pomona
country: United States
state: California
city: Roseville
country: United States
state: California
city: Tustin
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Jupiter
country: United States
state: Florida
city: Lauderdale lakes
country: United States
state: Florida
city: New Port Richey
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: Florissant
country: United States
state: Missouri
city: Berlin
country: United States
state: New Jersey
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Greer
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
References:
citation: Germino FW, Neutel JM, Dubiel R, Maa JF, Chavanu KJ. Efficacy of olmesartan medoxomil and hydrochlorothiazide fixed-dose combination therapy in patients aged 65 years and older with stage 1 and 2 hypertension or isolated systolic hypertension. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):325-33. doi: 10.1007/BF03261841.
citation: Neutel J, Kereiakes DJ, Stoakes KA, Maa JF, Shojaee A, Waverczak WF. Blood pressure-lowering efficacy of an olmesartan medoxomil/hydrochlorothiazide-based treatment algorithm in elderly patients (age >/=65 years) stratified by age, sex and race: subgroup analysis of a 12-week, open-label, single-arm, dose-titration study. Drugs Aging. 2011 Jun 1;28(6):477-90. doi: 10.2165/11589460-000000000-00000.