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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00185068
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2004-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Last Update Submitted: 2005-09-09
• Study First Posted: 2005-09-16
• Last Update Posted: 2005-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in mean trough seated systolic blood pressure compared to the start of the study

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure changes from baseline at the end of each titration period.
2. Percentage of patients responding to therapy
3. Percentage of patients achieving various blood pressure target goals