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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on April 23, 2014