HypertensionPhase 4NCT00362258
I PREVENT - Irbesartan In Hypertensive Diabetic Patients
A Phase 4 study testing Irbesartan (Aprovel) in people with Hypertension, run by Sanofi at 1 site in Egypt.
Trial summary
To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients. To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan (Aprovel)
- Type of treatment
- Pill or oral medicine
- How many people
- 797 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2006to Sep 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or without microalbuminuria).
- Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
- Patients who were receiving antihypertensive agents (maximum two agents, including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.
Who cannot join
- Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
- Patients with secondary hypertension.
- Patients with UAE > 200µg / min.
- Patients with HbA1c < 6% or > 10%.
- Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
- Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) > 2.5 times the upper limit of the normal range.
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- Currently pregnant or lactating females.
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
- Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
- Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.
- 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: Irbesartan In Hypertensive Diabetic Patients
- To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
- To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
- To demonstrate the safety of Irbesartan in this population.
- Conditions
- Hypertension
- Being tested
- Irbesartan (Aprovel)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan (Aprovel)Drug
Aprovel (150 \& 300mg) \& CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
Measured: During the study conduct
Secondary outcomes (3)
The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)
Measured: During the study conduct
First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions)
Measured: During the study conduct
Occurrence of any side effect leading to treatment discontinuation.
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2008
- Study completionSep 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Mosaad I Morsi, MBBCh, MSc, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362258
- Sponsor's protocol ID
- PM_L_0256
- Status last verified
- Mar 2011
- First submitted
- 8 Aug 2006
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irbesartan In Hypertensive Diabetic Patients
- ClinicalTrials.gov ID
- NCT00362258
- Acronym / sponsor ID
- PM_L_0256
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Aug 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.
- To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
- To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
- To demonstrate the safety of Irbesartan in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Proven Hypertensive Type 2 Diabetic Patients with HbA1c > 6% and ≤ 10% (with or without microalbuminuria).
- Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
- Patients who were receiving antihypertensive agents (maximum two agents, including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.
Key exclusion criteria (12 listed)
- Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
- Patients with secondary hypertension.
- Patients with UAE > 200µg / min.
- Patients with HbA1c < 6% or > 10%.
- Significant chronic renal impairment (Serum creatinine > 2.0 mg/dL).
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 (Aprovel)Aprovel (150 \& 300mg) \& CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os. | Drug | – |
Primary outcome
Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg.
Time frame: During the study conduct
3 secondary outcomes
The restoration of urinary albumin excretion (UAE) rate in patients with normoalbuminuria (UAE rate < 20µg / min)
Time frame: During the study conduct
First detection of overt nephropathy (UAE rate > 200µg / min), in patients with microalbuminuria or at least 30% higher than at baseline value(on at least two consecutive occasions)
Time frame: During the study conduct
Occurrence of any side effect leading to treatment discontinuation.
Time frame: During the study conduct
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 4 Apr 2011.
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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.
Mosaad I Morsi, MBBCh, MSc 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 (Aprovel) in people with Hypertension, run by Sanofi at 1 site in Egypt.
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 12 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 4 Apr 2011. 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 Egypt. 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?
Reach blood pressure target in hypertensive diabetic patients i.e. 130/80 mmHg. (time frame: During the study conduct). 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 4 Apr 2011.