Irbesartan/Hydrochlorothiazide National Taiwan University... | NCT00443612

Studies
Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

NCT00443612

Sponsor

Sanofi

Status

Completed

Last Update Posted

Oct 1, 2009Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Irbesartan/Hydrochlorothiazide
Irbesartan

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Not provided

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	12 weeks on treatment 1 2 week washout period 12 weeks on treatment 2	Drug: Irbesartan/Hydrochlorothiazide Drug: Irbesartan
2	Experimental	12 weeks on treatment 2 2 week washout period 12 weeks on treatment 1	Drug: Irbesartan/Hydrochlorothiazide Drug: Irbesartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan/Hydrochlorothiazide	Drug	Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forearm vascular resistance		At baseline and end of study
Changes of serum TBARS, CRP, IL-6, and VCAM-1		Throughout the study period
Office BP measurement of seated SBP and DBP		At baseline and after 12-week treatment
Adverse events		Throughout the study period

Secondary Outcomes

Measure	Description	Time Frame
Office BP measurement of seated SBP and DBP		At baseline and after 12-week treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Fern Lim	Sanofi	Study Director

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000077405	Irbesartan
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

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