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Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

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ClinicalTrials.gov Identifier: NCT00443612
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Irbesartan/Hydrochlorothiazide Drug: Irbesartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Study Start Date : September 2006
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Forearm vascular resistance [ Time Frame: At baseline and end of study ]
  2. Changes of serum TBARS, CRP, IL-6, and VCAM-1 [ Time Frame: Throughout the study period ]
  3. Office BP measurement of seated SBP and DBP [ Time Frame: At baseline and after 12-week treatment ]
  4. Adverse events [ Time Frame: Throughout the study period ]

Secondary Outcome Measures :
  1. Office BP measurement of seated SBP and DBP [ Time Frame: At baseline and after 12-week treatment ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443612


Locations
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Taiwan
Sanofi-Aventis
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Fern Lim Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00443612     History of Changes
Other Study ID Numbers: IRBEH_L_00702
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Irbesartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists