Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
- Conditions
- Hypertension
- Interventions
- Drug: Irbesartan/Hydrochlorothiazide
- Registration Number
- NCT00443612
- Lead Sponsor
- Sanofi
- 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, 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Irbesartan/Hydrochlorothiazide * 12 weeks on treatment 1 * 2 week washout period * 12 weeks on treatment 2 2 Irbesartan/Hydrochlorothiazide * 12 weeks on treatment 2 * 2 week washout period * 12 weeks on treatment 1 1 Irbesartan * 12 weeks on treatment 1 * 2 week washout period * 12 weeks on treatment 2 2 Irbesartan * 12 weeks on treatment 2 * 2 week washout period * 12 weeks on treatment 1
- Primary Outcome Measures
Name Time Method Forearm vascular resistance At baseline and end of study Changes of serum TBARS, CRP, IL-6, and VCAM-1 Throughout the study period Office BP measurement of seated SBP and DBP At baseline and after 12-week treatment Adverse events Throughout the study period
- Secondary Outcome Measures
Name Time Method Office BP measurement of seated SBP and DBP At baseline and after 12-week treatment
Trial Locations
- Locations (1)
Sanofi-Aventis
🇨🇳Taipei, Taiwan