Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Irbesartan/Hydrochlorothiazide; Drug: Irbesartan

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Throughout the study period
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 5, 2007
• First Submitted That Met QC Criteria: March 5, 2007
• First Posted (Estimate): March 6, 2007

Study Record Updates

• Last Update Posted (Estimate): October 1, 2009
• Last Update Submitted That Met QC Criteria: September 30, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Irbesartan
• Other Study ID Numbers: IRBEH_L_00702