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Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Irbesartan/Hydrochlorothiazide (Drug); Irbesartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Fern Lim, Study Director, Affiliation: Sanofi

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Forearm vascular resistance

Changes of serum TBARS, CRP, IL-6, and VCAM-1

Office BP measurement of seated SBP and DBP

Adverse events

Secondary outcome: Office BP measurement of seated SBP and DBP

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Taipei, Taiwan
Additional Information

Starting date: September 2006
Last updated: September 30, 2009

Page last updated: August 23, 2015

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