Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

Study Overview
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Brief Summary
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Primary: To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan 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: To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan 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) To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily 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

Official Title
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A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Irbesartan/Hydrochlorothiazide
* Drug: Irbesartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12 weeks on treatment 1 2 week washout period 12 weeks on treatment 2 | Drug: Irbesartan/Hydrochlorothiazide<br>* Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg<br>Drug: Irbesartan<br>* Administration of irbesartan 150 mg/day<br>|
| Experimental: 2<br>12 weeks on treatment 2 2 week washout period 12 weeks on treatment 1 | Drug: Irbesartan/Hydrochlorothiazide<br>* Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg<br>Drug: Irbesartan<br>* Administration of irbesartan 150 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office BP measurement of seated SBP and DBP |  | At baseline and after 12-week treatment |