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

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

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.

Intervention(s) in this Clinical Trial

• Drug: Irbesartan/HCTZ
  • Tablets, Oral, Irbesartan 150mg/HCTZ 12.5 mg, Once daily, 7 weeks.
• Drug: Irbesartan monotherapy
  • Tablets, Oral, 150 mg, Once daily, 7 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A1
• Active Comparator: A2

Primary Measures

• Proportion of subjects whose seated diastolic blood pressure is controlled (SeDBP < 90 mmHg) at Week 5

Secondary Measures

• Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 17 weeks of therapy.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095394

Study ID Number: CV131-176

ClinicalTrials.gov Identifier: NCT00095394

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm