HypertensionPhase 3I-COMBINENCT00956644
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
A Phase 3 study testing irbesartan/amlodipine and amlodipine in people with Hypertension, run by Sanofi at 40 sites in 9 countries.
Trial summary
Primary Objective: To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5) Secondary… 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/amlodipine and amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 40 sitesin 9 countries
- Study dates
- Jul 2009to Aug 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established essential hypertension
- Treated with amlodipine 5 mg monotherapy for at least 4 weeks
- With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM
- Signed written inform consent obtained prior to inclusion in the study
- Randomisation Criteria:
- Mean SBP = or > 135 mmHg assessed by HBPM
- Good compliance with the HBPM protocol defined as at least 12 correct measurements performed over the last 6 days of the first period of measurements
- Creatinine clearance = or > 30 ml/min, determined by Cockroft formula
Who cannot join
- Mean SBP = or > 180 mm Hg and/or mean DBP = or > 110 mm Hg measured at doctor's office at Visit 1
- Known or suspected causes of secondary hypertension
- Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only one functioning kidney
- Know contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
- Known type 1 diabetes
- Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or history or hepatic encephalopathy, esophageal varices, or portocaval shunt
Show all 15Show fewer
- Known severe renal impairment (creatinine clearance < 30 ml/mn)
- Concomitant use of any other antihypertensive treatment
- Administration of any other investigational drug within 30 days before inclusion
- Inability to obtain a valid automatic BP measurement recording
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the patient
- Presence of any other conditions (e.g.: geographical, social, etc) that would restrict or limit the patient participation for the duration of the study
- Pregnant or breast feeding women
- Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period
- 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
40 sites in 9 countries.
40 sites in 9 countries
Brazil8 sites
Sanofi-Aventis Investigational Site Number 07602
Campinas, 13059-900
Sanofi-Aventis Investigational Site Number 076-005
Rio de Janeiro, 20551-030
Sanofi-Aventis Investigational Site Number 07605
Rio de Janeiro, 20551-030
Sanofi-Aventis Investigational Site Number 07604
São José, 88103-460
Sanofi-Aventis Investigational Site Number 07601
São Paulo, 04025-011
Sanofi-Aventis Investigational Site Number 076-004
São Paulo, 04038-002
Sanofi-Aventis Investigational Site Number 076-002
São Paulo, 05403-000
Sanofi-Aventis Investigational Site Number 07603
São Paulo, 05403-000
Mexico7 sites
Sanofi-Aventis Investigational Site Number 48401
Durango, 34080
Sanofi-Aventis Investigational Site Number 48402
Guadalajara, 44656
Sanofi-Aventis Investigational Site Number 48403
Guadalajara, 44656
Sanofi-Aventis Investigational Site Number 48406
Guadalajara, 44670
Sanofi-Aventis Investigational Site Number 48404
Guadalajara, 44680
Sanofi-Aventis Investigational Site Number 48405
México, 06140
Sanofi-Aventis Investigational Site Number 48407
México, 07330
Chile5 sites
Sanofi-Aventis Investigational Site Number 15202
Santiago
Sanofi-Aventis Investigational Site Number 15203
Santiago
Sanofi-Aventis Investigational Site Number 15204
Santiago
Sanofi-Aventis Investigational Site Number 15205
Santiago
Sanofi-Aventis Investigational Site Number 15206
Santiago
Lebanon5 sites
Sanofi-Aventis Investigational Site Number 42202
Beirut
Sanofi-Aventis Investigational Site Number 42203
Beirut
Sanofi-Aventis Investigational Site Number 42204
Beirut
Sanofi-Aventis Investigational Site Number 42205
Beirut
Sanofi-Aventis Investigational Site Number 42206
Beirut
Egypt4 sites
Sanofi-Aventis Investigational Site Number 81803
Alexandria
Sanofi-Aventis Investigational Site Number 81804
Alexandria
Sanofi-Aventis Investigational Site Number 81801
Cairo
Sanofi-Aventis Investigational Site Number 81802
Cairo
Tunisia4 sites
Sanofi-Aventis Investigational Site Number 78804
Aryanah
Sanofi-Aventis Investigational Site Number 78803
Monastir, 5000
Sanofi-Aventis Investigational Site Number 78802
Sfax
Sanofi-Aventis Investigational Site Number 78801
Tunis
Colombia3 sites
Sanofi-Aventis Investigational Site Number 17003
Barranquilla
Sanofi-Aventis Investigational Site Number 17004
Barranquilla
Sanofi-Aventis Investigational Site Number 17002
Medellín
Morocco3 sites
Sanofi-Aventis Investigational Site Number 50401
Casablanca
Sanofi-Aventis Investigational Site Number 50402
Marrakesh
Sanofi-Aventis Investigational Site Number 50403
Marrakesh
About this study
Official title: Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
Primary Objective:
- To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5)
Read more
Secondary Objective:
- To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)
- To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10)
- To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)
- To determine the incidence and severity of adverse events
- Conditions
- Hypertension
- Being tested
- irbesartan/amlodipine, amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irbesartan/amlodipineDrug
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
amlodipineDrug
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| irbesartan/amlodipine | Experimental | Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks Receives: Drug: irbesartan/amlodipine |
| amlodipine | Active comparator | Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks Receives: Drug: amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean home systolic blood pressure
Measured: At randomisation and week 5
Secondary outcomes (2)
Mean office blood pressure
Measured: At randomisation, week 5 and week 10
Mean home diastolic blood pressure
Measured: At randomisation, week 5 and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathalie Genes, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956644
- Sponsor's protocol ID
- IRBAM_R_04220
- Acronym
- I-COMBINE
- Status last verified
- Oct 2010
- First submitted
- 10 Aug 2009
- Last updated
- 26 Oct 2010
- Results posted
- No
Publications
Bobrie G; I-COMBINE Study Investigators. I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1705-19. doi: 10.1016/j.clinthera.2012.06.026. Epub 2012 Jul 30.
PubMed 22853848
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00956644
- Acronym / sponsor ID
- I-COMBINE / IRBAM_R_04220
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Aug 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.
Primary Objective:
- To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5)
Secondary Objective:
- To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)
- To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10)
- To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)
- To determine the incidence and severity of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irbesartan/amlodipine | Experimental | Drug: irbesartan/amlodipineBefore randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks |
| amlodipine | Active comparator | Drug: amlodipineBefore randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Established essential hypertension
- Treated with amlodipine 5 mg monotherapy for at least 4 weeks
- With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM
- Signed written inform consent obtained prior to inclusion in the study
- Mean SBP = or > 135 mmHg assessed by HBPM
Key exclusion criteria (15 listed)
- Mean SBP = or > 180 mm Hg and/or mean DBP = or > 110 mm Hg measured at doctor's office at Visit 1
- Known or suspected causes of secondary hypertension
- Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only one functioning kidney
- Know contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
- Known type 1 diabetes
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/amlodipinePharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning | Drug | irbesartan/amlodipine |
| amlodipinePharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning | Drug | amlodipine |
Primary outcome
Mean home systolic blood pressure
Time frame: At randomisation and week 5
2 secondary outcomes
Mean office blood pressure
Time frame: At randomisation, week 5 and week 10
Mean home diastolic blood pressure
Time frame: At randomisation, week 5 and week 10
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 Oct 2010.
- Derived from this study: PubMed 22853848Bobrie G; I-COMBINE Study Investigators. I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1705-19. doi: 10.1016/j.clinthera.2012.06.026. Epub 2012 Jul 30.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Nathalie Genes, MD study director
Sanofi
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing irbesartan/amlodipine and amlodipine in people with Hypertension, run by Sanofi at 40 sites in 9 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 8 inclusion and 15 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 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Brazil, Mexico, Chile, Lebanon, Egypt and 4 more countries. 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 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?
Mean home systolic blood pressure (time frame: At randomisation and week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956644, which also lists 1 linked publication.
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 Oct 2010.