HypertensionPhase 4NCT00334581
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria
A Phase 4 study testing Irbesartan in people with Hypertension, run by Sanofi at 1 site in China.
Trial summary
Primary objective: To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria. Secondary objectives: To determine how well irbesartan 300mg is tolerated versus 150mg To determine the percentage of patients reaching the blood pressure… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- May 2006to Jun 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
- Blood pressure of < 180/110mmHg at baseline
- Normal serum creatinine
Who cannot join
- Type 1 diabetes
- Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
- Pregnant or lactating women
- Severe hypertension
- Overt nephropathy
- Allergy to study drug
- 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 Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
Primary objective:
- To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.
Secondary objectives:
- To determine how well irbesartan 300mg is tolerated versus 150mg
- To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg
- Conditions
- Hypertension
- Being tested
- Irbesartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Administration throughout the study period
IrbesartanDrug
Administration throughout the study period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Irbesartan 150mg Receives: Drug: Irbesartan |
| 2 | Experimental | Irbesartan 300mg Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of urinary albumin excretion rate change
Measured: at week 24
Secondary outcomes (2)
Percentage of patients reaching target BP of 130/80mmHg
Measured: At week 24
Adverse events
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2008
- Study completionJun 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Bruno Jolain, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334581
- Sponsor's protocol ID
- IRBES_L_00907
- Status last verified
- Sep 2009
- First submitted
- 7 Jun 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
- ClinicalTrials.gov ID
- NCT00334581
- Acronym / sponsor ID
- IRBES_L_00907
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Jun 2006 (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 objective:
- To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.
Secondary objectives:
- To determine how well irbesartan 300mg is tolerated versus 150mg
- To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IrbesartanIrbesartan 150mg |
| 2 | Experimental | Drug: IrbesartanIrbesartan 300mg |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
- Blood pressure of < 180/110mmHg at baseline
- Normal serum creatinine
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
- Pregnant or lactating women
- Severe hypertension
- Overt nephropathy
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 |
|---|---|---|
| IrbesartanAdministration throughout the study period | Drug | 1 |
| IrbesartanAdministration throughout the study period | Drug | 2 |
Primary outcome
The difference of urinary albumin excretion rate change
Time frame: at week 24
2 secondary outcomes
Percentage of patients reaching target BP of 130/80mmHg
Time frame: At week 24
Adverse events
Time frame: From the beginning to the end of the study
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 15 Sep 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.
Bruno Jolain 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 in people with Hypertension, run by Sanofi at 1 site in China.
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 3 inclusion and 7 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 15 Sep 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 China. 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?
The difference of urinary albumin excretion rate change (time frame: at week 24). 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 15 Sep 2009.