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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185068

Enrollment

110

Registered

2005-09-16

Start date

2004-03-31

Completion date

2004-10-31

Last updated

2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Systolic hypertension, Angiotensin receptor blocker

Brief summary

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

Interventions

DRUGOlmesartan medoxomil

DRUGOlmesartan medoxomil/hydrochlorothiazide

DRUGHydrochlorothiazide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in mean trough seated systolic blood pressure compared to the start of the study	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026