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

• ClinicalTrials.gov Identifier: NCT00185068
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: September 16, 2005
• Sponsor: Daiichi Sankyo, Inc.
• Information provided by: Daiichi Sankyo, Inc.

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: September 16, 2005
• Study Start Date: March 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 9, 2005): Change in mean trough seated systolic blood pressure compared to the start of the study
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 9, 2005)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Brief Summary: Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: Olmesartan medoxomil
• Drug: Olmesartan medoxomil/hydrochlorothiazide
• Drug: Hydrochlorothiazide

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 9, 2005): 110
• Original Enrollment: Same as current
• Study Completion Date: October 2004
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00185068
• Other Study ID Numbers: 866-443
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Daiichi Sankyo, Inc.
• Verification Date: September 2005