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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

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
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide Drug: Hydrochlorothiazide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in mean trough seated systolic blood pressure compared to the start of the study

Secondary Outcome Measures :
  1. 1. Blood pressure changes from baseline at the end of each titration period.
  2. 2. Percentage of patients responding to therapy
  3. 3. Percentage of patients achieving various blood pressure target goals

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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ClinicalTrials.gov Identifier: NCT00185068    
Other Study ID Numbers: 866-443
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005
Keywords provided by Daiichi Sankyo, Inc.:
Systolic hypertension, Angiotensin receptor blocker
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
 Natriuretic Agents
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