Clinical trial NCT00185068: An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
Official title: A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Systolic hypertension, Angiotensin receptor blocker
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 110
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: Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension


Eligibility criteria: Inclusion Criteria:

* 1. 18 years of age.
* 2. Patients with stage II systolic hypertension
* 3. 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:

* 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.

  2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.

  3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP \> 200 mm Hg).

  4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.

  5. Type I diabetes mellitus. 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, Atrial fibrillation, or Atrial Flutter.

  8. Laboratory test values considered clinically significant by the investigator.

  9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin \> 3 times the upper limit of normal.

  10. Pregnant or lactating females.
* 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.

Primary outcomes:
measure: Change in mean trough seated systolic blood pressure compared to the start of the study
Secondary outcomes:
measure: 1. Blood pressure changes from baseline at the end of each titration period.
measure: 2. Percentage of patients responding to therapy
measure: 3. Percentage of patients achieving various blood pressure target goals
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Anna
country: United States
state: California
city: Tustin
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Deland
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Orland Park
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Omaha
country: United States
state: Nebraska
city: Buffalo
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Madison
country: United States
state: Wisconsin
Study officials:
References: