HypertensionPhase 4NCT00443612
Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
A Phase 4 study testing Irbesartan/Hydrochlorothiazide and Irbesartan in people with Hypertension, run by Sanofi at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan/Hydrochlorothiazide and Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
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).
Read more
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
- Conditions
- Hypertension
- Being tested
- Irbesartan/Hydrochlorothiazide, Irbesartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan/HydrochlorothiazideDrug
Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg
IrbesartanDrug
Administration of irbesartan 150 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * 12 weeks on treatment 1
* 2 week washout period
* 12 weeks on treatment 2 Receives: Drug: Irbesartan/Hydrochlorothiazide; Drug: Irbesartan |
| 2 | Experimental | * 12 weeks on treatment 2
* 2 week washout period
* 12 weeks on treatment 1 Receives: Drug: Irbesartan/Hydrochlorothiazide; Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm vascular resistance
Measured: At baseline and end of study
Changes of serum TBARS, CRP, IL-6, and VCAM-1
Measured: Throughout the study period
Office BP measurement of seated SBP and DBP
Measured: At baseline and after 12-week treatment
Adverse events
Measured: Throughout the study period
Secondary outcomes (1)
Office BP measurement of seated SBP and DBP
Measured: At baseline and after 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fern Lim, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443612
- Sponsor's protocol ID
- IRBEH_L_00702
- Status last verified
- Sep 2009
- First submitted
- 5 Mar 2007
- Last updated
- 1 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Cross-over Comparative Study of Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00443612
- Acronym / sponsor ID
- IRBEH_L_00702
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irbesartan/Hydrochlorothiazide, Drug: Irbesartan* 12 weeks on treatment 1 * 2 week washout period * 12 weeks on treatment 2 |
| 2 | Experimental | Drug: Irbesartan/Hydrochlorothiazide, Drug: Irbesartan* 12 weeks on treatment 2 * 2 week washout period * 12 weeks on treatment 1 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irbesartan/HydrochlorothiazideAdministration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg | Drug | 1, 2 |
| IrbesartanAdministration of irbesartan 150 mg/day | Drug | 1, 2 |
Primary outcome
Forearm vascular resistance
Time frame: At baseline and end of study
Changes of serum TBARS, CRP, IL-6, and VCAM-1
Time frame: Throughout the study period
Office BP measurement of seated SBP and DBP
Time frame: At baseline and after 12-week treatment
Adverse events
Time frame: Throughout the study period
1 secondary outcome
Office BP measurement of seated SBP and DBP
Time frame: At baseline and after 12-week treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fern Lim study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan/Hydrochlorothiazide and Irbesartan in people with Hypertension, run by Sanofi at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm vascular resistance (time frame: At baseline and end of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.