Clinical trial NCT00443612: Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
Official title: A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Forearm vascular resistance
timeFrame: At baseline and end of study
measure: Changes of serum TBARS, CRP, IL-6, and VCAM-1
timeFrame: Throughout the study period
measure: Office BP measurement of seated SBP and DBP
timeFrame: At baseline and after 12-week treatment
measure: Adverse events
timeFrame: Throughout the study period
Secondary outcomes:
measure: Office BP measurement of seated SBP and DBP
timeFrame: At baseline and after 12-week treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Fern Lim
role: STUDY_DIRECTOR
References: