Hypertension
Conditions
Keywords
Moderate Hypertension
Brief summary
The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
Interventions
DRUGIrbesartan/HCTZ
Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
Tablets, Oral, 150 mg, Once daily, 12 weeks.
DRUGHCTZ monotherapy
Tablets, Oral, 12.5 mg, Once daily, 12 weeks.
Sponsors
Sanofi
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to provide written informed consent * Subjects must have uncontrolled hypertension defined as: * average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or * average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg) * Subjects must be willing to discontinue their antihypertensive medication, if applicable. * Men and women, ages 18 and older will be included. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.
Exclusion criteria
* Women who are pregnant or breastfeeding * Known or suspected secondary hypertension * Hypertension emergencies or stroke within the past 12 months. * Heart attack, angina or bypass surgery within the past six months. * Significant kidney disease * Significant liver disease * Systemic lupus erythematosus * Gastrointestinal disease or surgery that interfere with drug absorption * Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin * Currently pregnant or lactating * Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study * Drug or alcohol abuse within the last five years * Known allergy to irbesartan or diuretics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SeSBP at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy. | — |
Countries
Canada, France, Germany, Russia, United States
Outcome results
None listed