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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Irbesartan/HCTZ
  • Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
• Drug: Irbesartan monotherapy
  • Tablets, Oral, 150 mg, Once daily, 12 weeks.
• Drug: HCTZ monotherapy
  • Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A1
• Active Comparator: A2
• Active Comparator: A3

Primary Measures

• Change from baseline in SeSBP at Week 8

Secondary Measures

• Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.

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

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 Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095550

Study ID Number: CV131-185

ClinicalTrials.gov Identifier: NCT00095550

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