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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
This study has been completed.
First Received: September 9, 2005   No Changes Posted
Sponsor: Daiichi Sankyo Inc.
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00185068
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Olmesartan medoxomil
Drug: Olmesartan medoxomil/hydrochlorothiazide
Drug: Hydrochlorothiazide
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 110
Study Start Date: March 2004
Estimated Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185068

Locations
United States, California
Long Beach, California, United States
Westlake Village, California, United States
Roseville, California, United States
Sacramento, California, United States
Fort Lauderdale, California, United States
Santa Anna, California, United States
Tustin, California, United States
United States, Florida
Pembroke Pines, Florida, United States
Deland, 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

No publications provided

Study ID Numbers: 866-443
Study First Received: September 9, 2005
Last Updated: September 9, 2005
ClinicalTrials.gov Identifier: NCT00185068     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Systolic hypertension, Angiotensin receptor blocker

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010