Hypertension
Conditions
Keywords
Severe Hypertension
Brief summary
The purpose of this clinical research is to learn if severe 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 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
Tablets, Oral, 150 mg, Once daily, 7 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
* Men and women ages 18 and older; * Willing to provide written informed consent; * Must have uncontrolled hypertension defined as: currently untreated with a diastolic blood pressure greater than 110 mmHg OR currently receiving antihypertensive monotherapy with a diastolic blood pressure greater than 100 mmHg. Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy; * Must be willing to discontinue antihypertensive medication, if applicable; * 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 6 months; * Significant kidney disease; * Significant liver disease; * Systemic lupus erythematosus; * Gastrointestinal disease or surgery that may 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 |
|---|---|
| Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy. | — |
Countries
Belgium, Canada, France, Germany, Israel, Netherlands, Russia, United States
Outcome results
None listed