Hypertension
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.
Detailed description
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.
Interventions
DRUGIRBESARTAN
150/12.5 mg tablets one or two tablets orally per day
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have hypertension and uncontrolled SBP on monotherapy. * Patients who have read, signed and received a copy of the informed consent prior to any study procedures Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.
Exclusion criteria
* Any history of secondary hypertension * History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months * History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean SBP | from baseline to week 18 |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean DBP | from baseline to week 18. |
| Changes in mean SBP and DBP | from baseline to week 10 |
| SBP and DBP response and control rates | at weeks 10 and 18 |
Countries
United States
Outcome results
None listed