HypertensionPhase 2I-COMBONCT00950066
Irbesartan and Amlodipine Combination in Controlling Blood Pressure
A Phase 2 study testing IRBESARTAN (SR47436), Amlodipine and Irbesartan / Amlodipine in people with Hypertension, run by Sanofi at 4 sites in 4 countries.
Trial summary
The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- IRBESARTAN (SR47436), Amlodipine and Irbesartan / Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2009to Jan 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with uncomplicated mild to moderate essential hypertension (as per European Society of Cardiology Classification of Hypertension)
- Treatment naïve subjects (newly diagnosed subjects or subjects currently only on lifestyle modification) with mean SeDBP of 95 to 109 mmHg at both screening and randomization visit (mean of 3 recordings at intervals of 1 minute) Or
- Uncontrolled on any anti-hypertensive monotherapy and with mean SeDBP of 90 to 109 mmHg at screening and mean SeDBP of 95 to 109 mmHg at the randomization visit (mean of 3 recordings at intervals of 1 minute).
- Signed written informed consent obtained prior to inclusion in the study.
- Subjects willing to adhere to protocol and study requirements during the entire study duration.
- Subjects having no abnormalities in general physical examination.
Who cannot join
- Subjects who are incapable of giving informed consent for the study.
- Subjects with SeDBP > or = 110mmHg and / or SeSBP > or = 180 mmHg measured at Doctor's office during screening or randomization visit
- Subjects having a difference of > 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.
- Subjects who are on any anti-hypertensive therapy and unable to discontinue the anti-hypertensive therapy safely for a period of at least 2 weeks as required by the protocol.
- Subjects who cannot be discontinued on medications prohibited by the protocol.
- Subjects on combination therapies for treatment of hypertension.
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- Subjects with known documented secondary hypertension including (but not limited to) hypertension secondary to coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- Subjects with known diabetes (Type 1 or Type 2).
- Subjects with known documented complications of hypertension including (but not limited to):
- Cardiovascular disease: Ischemic heart disease (angina, myocardial infarction), heart failure, peripheral vascular disease.
- Cerebrovascular disease: Stroke, cerebral hemorrhage.
- Ophthalmic: Retinal hemorrhage, impaired vision, retinal microaneurysms.
- Subjects with known severe renal impairment (creatinine clearance < 30 ml/min) calculated using the Cockcroft-Gault equation.
- Subjects with hyperkalemia (>5.1mmol/L) and/or hyponatremia (<133mmol/L).
- Subjects with known severe hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt.
- Subjects with clinically significant abnormalities on ECG
- Subjects with any other clinical condition which, in the opinion of the Investigator, might interfere with administration of Irbesartan or Amlodipine and evaluation of the study objectives.
- Subjects with known history of allergy considered due to any of the study drugs or their components, including excipients (lactose) and preservatives.
- Subjects with known history of substance abuse (drug or alcohol dependency, alcohol, if not stopped, <20gms per day will be allowed during the study period).
- Subjects known positive for HIV 1 or 2 virus.
- Subjects with known or suspected impairment of the immune function, and/or receiving immunosuppressive therapy, or having received immunosuppressive therapy within 30 days prior to study entry.
- Subjects who have received any other investigational drug within 30 days before inclusion.
- Pregnant (demonstrating a positive serum (ß-HCG) pregnancy test at screening visit) or lactating female subjects.
- Subjects and partners unwilling to employ adequate contraception during the course of the study.
- 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
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension
The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo.
The secondary objectives are:
- to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
- to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
- Conditions
- Hypertension
- Being tested
- IRBESARTAN (SR47436), Amlodipine, Irbesartan / Amlodipine, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRBESARTAN (SR47436)Drug
Oral administration of Irbesartan 150mg or 300mg once a day
AmlodipineDrug
Oral administration of Amlodipine 5mg once a day
Irbesartan / AmlodipineDrug
Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day
PlaceboDrug
Oral administration of a placebo once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with placebo once a day. Receives: Drug: Placebo |
| Irbesartan 150mg | Active comparator | Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 150 mg once a day. Receives: Drug: IRBESARTAN (SR47436) |
| Irbesartan 150 mg / Amlodipine 5 mg | Active comparator | Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day. Receives: Drug: Irbesartan / Amlodipine |
| Amlodipine | Active comparator | Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Amlodipine 5 mg once a day. Receives: Drug: Amlodipine |
| Irbesartan 300 mg | Active comparator | Active Comparator: Irbesartan
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 300 mg once a day. Receives: Drug: IRBESARTAN (SR47436) |
| Irbesartan 300 mg / Amlodipine 5 mg | Active comparator | Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day. Receives: Drug: Irbesartan / Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
Measured: At week 0, week 2, week 4 and week 8
Secondary outcomes (2)
Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Measured: At week 0, week 2, week 4 and week 8
Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Measured: At week 0, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sanjay Aggarwal, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950066
- Sponsor's protocol ID
- IRBES_R_04320
- Acronym
- I-COMBO
- Status last verified
- Jan 2011
- First submitted
- 30 Jul 2009
- Last updated
- 5 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00950066
- Acronym / sponsor ID
- I-COMBO / IRBES_R_04320
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Jul 2009 (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.
The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo.
The secondary objectives are:
- to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
- to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboBefore randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with placebo once a day. |
| Irbesartan 150mg | Active comparator | Drug: IRBESARTAN (SR47436)Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg once a day. |
| Irbesartan 150 mg / Amlodipine 5 mg | Active comparator | Drug: Irbesartan / AmlodipineBefore randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day. |
| Amlodipine | Active comparator | Drug: AmlodipineBefore randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Amlodipine 5 mg once a day. |
| Irbesartan 300 mg | Active comparator | Drug: IRBESARTAN (SR47436)Active Comparator: Irbesartan Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg once a day. |
| Irbesartan 300 mg / Amlodipine 5 mg | Active comparator | Drug: Irbesartan / AmlodipineBefore randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with uncomplicated mild to moderate essential hypertension (as per European Society of Cardiology Classification of Hypertension)
- Signed written informed consent obtained prior to inclusion in the study.
- Subjects willing to adhere to protocol and study requirements during the entire study duration.
- Subjects having no abnormalities in general physical examination.
Key exclusion criteria (25 listed)
- Subjects who are incapable of giving informed consent for the study.
- Subjects with SeDBP > or = 110mmHg and / or SeSBP > or = 180 mmHg measured at Doctor's office during screening or randomization visit
- Subjects having a difference of > 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.
- Subjects who are on any anti-hypertensive therapy and unable to discontinue the anti-hypertensive therapy safely for a period of at least 2 weeks as required by the protocol.
- Subjects who cannot be discontinued on medications prohibited by the protocol.
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 (SR47436)Oral administration of Irbesartan 150mg or 300mg once a day | Drug | Irbesartan 150mg, Irbesartan 300 mg |
| AmlodipineOral administration of Amlodipine 5mg once a day | Drug | Amlodipine |
| Irbesartan / AmlodipineOral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day | Drug | Irbesartan 150 mg / Amlodipine 5 mg, Irbesartan 300 mg / Amlodipine 5 mg |
| PlaceboOral administration of a placebo once a day | Drug | Placebo |
Primary outcome
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4 and week 8
2 secondary outcomes
Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4 and week 8
Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo
Time frame: At week 0, week 2, week 4
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 5 Jan 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.
Sanjay Aggarwal, MD study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IRBESARTAN (SR47436), Amlodipine and Irbesartan / Amlodipine in people with Hypertension, run by Sanofi at 4 sites in 4 countries.
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 6 inclusion and 25 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 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, Philippines, South Korea, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo (time frame: At week 0, week 2, week 4 and week 8). 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 5 Jan 2011.