The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First LineTreatment for Severe Hypertensio

• Conditions: Severe Hypertension

• Registration Number: EUCTR2004-000020-32-BE
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-27
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

* Subjects must have uncontrolled hypertension defined as:
• currently untreated with an SeDBP = 110mmHg
OR
• currently receiving antihypertensive monotherapy with an SeDBP = 100mmHg.
Monotherapy is defined as treatment with one antihypertensive medication for at least four weeks; fixed combination therapy does not represent monotherapy.
* Subjects must be willing to discontinue their antihypertensive medication, if
applicable.

To qualify for randomization to double-blind therapy:
- all evaluations including laboratory testing from the Enrollment Visit must be
completed and the results must satisfy all selection criteria,
- blood pressure measurement of an averaged SeDBP = 110mmHg must be
demonstrated at two consecutive visits (A01 and A99) off of medication and immediately prior to randomization (see Section 7.3.4 for BP standardization).

* Men and women, ages 18 and older will be included.
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study
medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* SeSBP = 220mmHg or SeDBP = 130mmHg and/or evidence of malignant or
accelerated hypertension or clinical evidence that the subject requires immediate
lowering of his/her blood pressure within hours, including, but not limited to coronary
ischemia or neurological signs and symptoms.
* Known or suspected secondary hypertension.
* Hypertensive encephalopathy, stroke, or transient ischemic attack within the past 12 months
* Myocardial infarction, percutaneous transluminal coronary revascularization,
coronary artery bypass graft, or unstable angina pectoris within the past six months
* New York Heart Association functional class III-IV congestive heart failure, or LV
dysfunction requiring ACE inhibitor
* Hemodynamically significant cardiac valvular disease
* Heart block greater than first degree atrioventricular block, preexcitation syndrome,
sick sinus syndrome, chronic atrial fibrillation, or chronic atrial flutter, or other
significant arrhythmias that may interfere with the blood pressure measurements
* Significant chronic renal impairment, or renovascular disease
* Significant liver disease
* Systemic lupus erythematosus
* Obesity that would limit accurate blood pressure measurement
* Positive pregnancy test
* Serum creatinine > 1.5 mg/dL
* AST, ALT, or total bilirubin > 3 times the upper limit of normal
* Plasma glucose > 240 mg/dL (if high, may be repeated once)
* Hemoglobin A1c > 10%
* Serum potassium < 3.3 or > 5.5 mmol/l
* White blood cell count < 2,600/µl
* Platelet count < 100,000/µl
* Hb < 10g/dL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified