An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00185068

Collaborator

(none)

110

Enrollment

Locations

Duration (Months)

6.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 1, 2004

Study Completion Date :

Oct 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 18 years of age.
1. Patients with stage II systolic hypertension
1. 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.

History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.
Laboratory test values considered clinically significant by the investigator.
Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.
Pregnant or lactating females.

1. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.

Contacts and Locations

Locations

	City	State	Country
1	Fort Lauderdale	California	United States
2	Long Beach	California	United States
3	Roseville	California	United States
4	Sacramento	California	United States
5	Santa Anna	California	United States
6	Tustin	California	United States
7	Westlake Village	California	United States
8	Deland	Florida	United States
9	Pembroke Pines	Florida	United States
10	Orland Park	Illinois	United States
11	New Orleans	Louisiana	United States
12	Auburn	Maine	United States
13	Omaha	Nebraska	United States
14	Buffalo	New York	United States
15	Oklahoma City	Oklahoma	United States
16	Madison	Wisconsin	United States