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Completed

NCT Number: NCT00443612

Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan/hydrochlorothiazide

Drug

Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg

Irbesartan

Drug

Administration of irbesartan 150 mg/day

Primary outcomes

  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 outcomes

  1. Office BP measurement of seated SBP and DBP

    Time frame: At baseline and after 12-week treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
First posted
Mar 6, 2007
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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