HypertensionPhase 3PRIMENCT00561964
Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
A Phase 3 study testing Irbesartan in people with Hypertension, run by Sanofi.
Trial summary
To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jul 2005
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment > 3 months
- The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
- Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be <35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
- Serum creatinine < 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
- 18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2
Who cannot join
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.
- Conditions
- Hypertension
- Being tested
- Irbesartan, placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Irbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end)
placeboDrug
Placebo group: 2 placebo capsules daily as a single morning intake
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Irbesartan |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine albumin excretion rate (UAER)
Measured: during the study conduct
Secondary outcomes (1)
SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin
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 posted21 Nov 2007 (estimated)
- Study startJan 2004
- Study completionJul 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Martin Thoenes, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561964
- Sponsor's protocol ID
- L_9079
- Acronym
- PRIME
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 26 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria
- ClinicalTrials.gov ID
- NCT00561964
- Acronym / sponsor ID
- PRIME / L_9079
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Nov 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.
To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irbesartan |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment > 3 months
- The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
- Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be <35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
- Serum creatinine < 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
- 18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2
Key exclusion criteria (1 listed)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| IrbesartanIrbesartan capsules strength 150 mg. Irbesartan group will be initiated at one irbesartan and one placebo for 2 weeks and titrated at two capsules if well tolerated after 2 weeks , this dose will be maintained throughout the study without further dose-adjustment (2 capsules daily in the morning will be taken from randomization to study end) | Drug | 1 |
| placeboPlacebo group: 2 placebo capsules daily as a single morning intake | Drug | 2 |
Primary outcome
Urine albumin excretion rate (UAER)
Time frame: during the study conduct
1 secondary outcome
SeSBP, SeDBP, Total cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol , glycated hemoglobin
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 26 Nov 2007.
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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.
Martin Thoenes study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Hypertension, run by Sanofi.
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 5 inclusion and 1 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 26 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Urine albumin excretion rate (UAER) (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 26 Nov 2007.