An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Olmesartan medoxomil; Drug: Olmesartan medoxomil/hydrochlorothiazide; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185068

866-443

Details and patient eligibility

About

Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

  6. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.

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

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

  9. Pregnant or lactating females.

• 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)