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Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
This study has been completed.
Study NCT00443612   Information provided by Sanofi-Aventis
First Received: March 5, 2007   Last Updated: September 30, 2009   History of Changes

March 5, 2007
September 30, 2009
September 2006
October 2008   (final data collection date for primary outcome measure)
  • Forearm vascular resistance [ Time Frame: At baseline and end of study ] [ Designated as safety issue: No ]
  • Changes of serum TBARS, CRP, IL-6, and VCAM-1 [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Office BP measurement of seated SBP and DBP [ Time Frame: At baseline and after 12-week treatment ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
  • Forearm vascular resistance
  • Changes of serum TBARS, CRP, IL-6, and VCAM-1
  • Office BP measurement of seated SBP and DBP at baseline and after 12-week treatment
  • Adverse events
Complete list of historical versions of study NCT00443612 on ClinicalTrials.gov Archive Site
Office BP measurement of seated SBP and DBP [ Time Frame: At baseline and after 12-week treatment ] [ Designated as safety issue: No ]
  • Safety
  • The incidence of adverse events and marked laboratory abnormalities in each treatment will be compared using Chi square or Fisher's Exact Test
 
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
 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Hypertension
  • Drug: Irbesartan/Hydrochlorothiazide
  • Drug: Irbesartan
  • Experimental:
    • 12 weeks on treatment 1
    • 2 week washout period
    • 12 weeks on treatment 2
  • Experimental:
    • 12 weeks on treatment 2
    • 2 week washout period
    • 12 weeks on treatment 1
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
October 2008   (final data collection date for primary outcome measure)

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.

Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00443612
Medical Affairs Study Director, sanofi-aventis
IRBEH_L_00702
Sanofi-Aventis
 
Study Director: Fern Lim Sanofi-Aventis
Sanofi-Aventis
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP