NCT00443612

Brief Summary

Primary:

  1. 1.To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
  2. 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).
  3. 3.To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
  4. 4.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)
  5. 5.To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily
  6. 6.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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

2.1 years

First QC Date

March 5, 2007

Last Update Submit

September 30, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Office BP measurement of seated SBP and DBP

    At baseline and after 12-week treatment

Study Arms (2)

1

EXPERIMENTAL

* 12 weeks on treatment 1 * 2 week washout period * 12 weeks on treatment 2

Drug: Irbesartan/HydrochlorothiazideDrug: Irbesartan

2

EXPERIMENTAL

* 12 weeks on treatment 2 * 2 week washout period * 12 weeks on treatment 1

Drug: Irbesartan/HydrochlorothiazideDrug: Irbesartan

Interventions

Irbesartan/HydrochlorothiazideDRUG

Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg

12
IrbesartanDRUG

Administration of irbesartan 150 mg/day

12

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

IrbesartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Fern Lim

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 6, 2007

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

TW(1)