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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Olmesartan medoxomil (Drug); Olmesartan medoxomil/hydrochlorothiazide (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in mean trough seated systolic blood pressure compared to the start of the study

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Fort Lauderdale, California, United States

Long Beach, California, United States

Roseville, California, United States

Sacramento, California, United States

Santa Anna, California, United States

Tustin, California, United States

Westlake Village, California, United States

Deland, Florida, United States

Pembroke Pines, Florida, United States

Orland Park, Illinois, United States

New Orleans, Louisiana, United States

Auburn, Maine, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

Oklahoma City, Oklahoma, United States

Madison, Wisconsin, United States

Additional Information

Starting date: March 2004
Last updated: September 9, 2005

Page last updated: August 20, 2015

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