Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

NCT ID: NCT00443612

Last Updated: 2009-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

• 12 weeks on treatment 1
• 2 week washout period
• 12 weeks on treatment 2

Group Type: EXPERIMENTAL

Irbesartan/Hydrochlorothiazide

Intervention Type: DRUG

Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg

Irbesartan

Intervention Type: DRUG

Administration of irbesartan 150 mg/day

2

• 12 weeks on treatment 2
• 2 week washout period
• 12 weeks on treatment 1

Group Type: EXPERIMENTAL

Irbesartan/Hydrochlorothiazide

Intervention Type: DRUG

Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg

Irbesartan

Intervention Type: DRUG

Administration of irbesartan 150 mg/day

Interventions

Irbesartan/Hydrochlorothiazide

Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg

Intervention Type: DRUG

Irbesartan

Administration of irbesartan 150 mg/day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Fern Lim

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

IRBEH_L_00702

Identifier Type: -

Identifier Source: org_study_id