An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00185068|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide Drug: Hydrochlorothiazide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2004|
|Study Completion Date :||October 2004|
- Change in mean trough seated systolic blood pressure compared to the start of the study
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185068
|United States, California|
|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|
|United States, Florida|
|Deland, Florida, United States|
|Pembroke Pines, Florida, United States|
|United States, Illinois|
|Orland Park, Illinois, United States|
|United States, Louisiana|
|New Orleans, Louisiana, United States|
|United States, Maine|
|Auburn, Maine, United States|
|United States, Nebraska|
|Omaha, Nebraska, United States|
|United States, New York|
|Buffalo, New York, United States|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States|
|United States, Wisconsin|
|Madison, Wisconsin, United States|
|Other Study ID Numbers:||
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||September 16, 2005|
|Last Verified:||September 2005|
Systolic hypertension, Angiotensin receptor blocker
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists