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

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00185068

First received: September 9, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information
First Received Date ^ICMJE	September 9, 2005
Last Updated Date	September 9, 2005
Start Date ^ICMJE	March 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2005)	Change in mean trough seated systolic blood pressure compared to the start of the study
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (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 ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide Drug: Hydrochlorothiazide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Estimated Completion Date	October 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00185068
Other Study ID Numbers ^ICMJE	866-443
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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