Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00443612

Purpose

Primary:

To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
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:

To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
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)
To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
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	Intervention	Phase
Hypertension	Drug: Irbesartan/Hydrochlorothiazide Drug: Irbesartan	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label, Cross-Over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Office BP measurement of seated SBP and DBP [ Time Frame: At baseline and after 12-week treatment ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	September 2006
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443612

Locations

Taiwan
Sanofi-Aventis
Taipei, Taiwan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Fern Lim

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	IRBEH_L_00702
Study First Received:	March 5, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00443612
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Irbesartan
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors

Physiological Effects of Drugs
Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009