Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: IRBESARTAN/HYDROCHLOROTHIAZIDE (Drug); irbesartan (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Fern Lim, Study Director, Affiliation: Sanofi-Aventis
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, markers of cardiovascular risks,
oxidative stress and circulating adhesion molecule including thiobarbiturate acid
reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and
vascular cell adhesion molecule 1 (VCAM-1).
Secondary:
1. To compare the reduction in office blood pressure following a 12-week regimen of
irbesartan/hydrochlorothiazide versus irbesartan
2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic
blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate
(defined as SBP<140 mmHg and /or DBP<90 mmHg)
3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus
irbesartan when administered once daily
4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including
A1166C gene with about 4% of the minor allele frequency in Chinese population and other
single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is
related to reduction of BP
Clinical Details
Official title: A Randomized, Open Label, Cross-Over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Forearm vascular resistanceChanges of serum TBARS, CRP, IL-6, and VCAM-1 Office BP measurement of seated SBP and DBP Adverse events
Secondary outcome: Office BP measurement of seated SBP and DBP
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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 Criteria:
- 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.
Locations and Contacts
Sanofi-Aventis, Taipei, Taiwan
Additional Information
Starting date: September 2006
Last updated: March 12, 2008
|
