Status:
COMPLETED
Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
Brief Summary
Primary: 1. To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan 2. To assess changes of serum proinflammatory cytokine...
Eligibility Criteria
Inclusion
- Patients with mild to moderate hypertension with office diastolic BP (DBP) 90-109 mmHg and/or systolic BP (SBP) 140-179 mmHg before entering each treatment
Exclusion
- females: who are pregnant or breast feeding
- office DBP ≧ 110 mmHg or office SBP ≧ 180 mmHg
- history of significant cardiovascular diseases which include: acute myocardial infarction within six months or any ischemic heart disease requiring medication, or cerebrovascular disease
- history of significant renal diseases including: serum creatinine \> 3.0 mg/dl, or creatinine clearance \< 30 ml/min.
- severe biliary cirrhosis and cholestasis
- refractory hypokalemia, hypercalcemia
- history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
- hepatic disease as indicated by any of the following : Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvate Transaminase (SGPT) \>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00443612
Start Date
September 1 2006
Last Update
October 1 2009
Active Locations (1)
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1
Sanofi-Aventis
Taipei, Taiwan