Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
Study Details
Study Description
Brief Summary
Primary:
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To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
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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:
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To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
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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)
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To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 12 weeks on treatment 1 2 week washout period 12 weeks on treatment 2 |
Drug: Irbesartan/Hydrochlorothiazide
Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
Drug: Irbesartan
Administration of irbesartan 150 mg/day
|
| Experimental: 2 12 weeks on treatment 2 2 week washout period 12 weeks on treatment 1 |
Drug: Irbesartan/Hydrochlorothiazide
Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
Drug: Irbesartan
Administration of irbesartan 150 mg/day
|
Outcome Measures
Primary Outcome Measures
- 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
- Office BP measurement of seated SBP and DBP [At baseline and after 12-week treatment]
Eligibility Criteria
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:
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females: who are pregnant or breast feeding
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office DBP ≧ 110 mmHg or office SBP ≧ 180 mmHg
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history of significant cardiovascular diseases which include: acute myocardial infarction within six months or any ischemic heart disease requiring medication, or cerebrovascular disease
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history of significant renal diseases including: serum creatinine > 3.0 mg/dl, or creatinine clearance < 30 ml/min.
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severe biliary cirrhosis and cholestasis
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refractory hypokalemia, hypercalcemia
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history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Taipei | Taiwan |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Fern Lim, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRBEH_L_00702