Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan/HCTZ
* Drug: Irbesartan monotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Irbesartan/HCTZ<br>* Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.<br>* Other names: Avapro;|
| Active Comparator: A2<br> | Drug: Irbesartan monotherapy<br>* Tablets, Oral, 150 mg, Once daily, 7 weeks.<br>* Other names: Avapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Hypertension