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

September 9, 2005
September 9, 2005
March 2004
Not Provided
Change in mean trough seated systolic blood pressure compared to the start of the study
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Olmesartan medoxomil
  • Drug: Olmesartan medoxomil/hydrochlorothiazide
  • Drug: Hydrochlorothiazide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
October 2004
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185068
866-443
Not Provided
Not Provided
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP