HypertensionPhase 4ACTUALNCT00708344
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
A Phase 4 study testing Irbesartan - Hydrochlorothiazide in people with Hypertension, run by Sanofi at 16 sites in 16 countries.
Trial summary
To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week… 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 - Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 16 sitesin 16 countries
- Study dates
- Jun 2008to Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone
- With uncontrolled Blood Pressure (BP) defined as:
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
- SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients
Who cannot join
- SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
- Known or suspected causes of secondary hypertension
- Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney
- Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc…).
- Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
- Known contraindications to the study drugs:
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- Severe renal dysfunction (creatinine clearance <30ml/min)
- Known hypokaliemia (< 3 mmol/L) , known hypercalcemia
- Severe hepatic impairment, biliary cirrhosis, cholestasis
- Inability to obtain a valid automatic BP measurement recording
- Administration of any other investigational drug within 30 days prior to study entry and during the course of the study
- 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 subject.
- Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study.
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control
- 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
16 sites in 16 countries.
16 sites in 16 countries
United Arab Emirates1 site
Sanofi-Aventis Administrative Office
Dubai
About this study
Official title: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy
To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.
- Conditions
- Hypertension
- Being tested
- Irbesartan - Hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan - HydrochlorothiazideDrug
150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks
Irbesartan - HydrochlorothiazideDrug
150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Usual elective titration regimen Receives: Drug: Irbesartan - Hydrochlorothiazide |
| Group 2 | Active comparator | Active elective titration regimen Receives: Drug: Irbesartan - Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Systolic Blood Pressure
Measured: between Visit 1 (Week 0) and Visit 4 (Week 10)
Secondary outcomes (1)
Change in mean Diastolic Blood Pressure
Measured: between Visit 1 (Week 0) and Visit 4 (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 832 participants (actual)
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
- NCT00708344
- Sponsor's protocol ID
- IRBEH_R_02931
- Acronym
- ACTUAL
- Status last verified
- Jul 2010
- First submitted
- 27 Jun 2008
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Girerd X, Rosenbaum D, Aoun J; ACTUAL study Investigators. Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study. Blood Press Suppl. 2011 Dec;2:22-9. doi: 10.3109/08037051.2011.633368.
PubMed 22352122
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination: A Comparison of Active and Usual Titration Regimen in the Treatment of Hypertensive Patients Insufficiently Controlled by Monotherapy
- ClinicalTrials.gov ID
- NCT00708344
- Acronym / sponsor ID
- ACTUAL / IRBEH_R_02931
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Jul 2008 (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 compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Irbesartan - HydrochlorothiazideUsual elective titration regimen |
| Group 2 | Active comparator | Drug: Irbesartan - HydrochlorothiazideActive elective titration regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone
- With uncontrolled Blood Pressure (BP) defined as:
- SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
- SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients
Key exclusion criteria (16 listed)
- SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
- Known or suspected causes of secondary hypertension
- Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney
- Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc…).
- Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
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 - Hydrochlorothiazide150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Duration of treatment : 10 weeks | Drug | Group 1 |
| Irbesartan - Hydrochlorothiazide150/12.5 mg (1 tablet once daily) or 300/25 mg (1 tablet once daily) depending on the control of the blood pressure. Treatment duration : 10 weeks | Drug | Group 2 |
Primary outcome
Change in mean Systolic Blood Pressure
Time frame: between Visit 1 (Week 0) and Visit 4 (Week 10)
1 secondary outcome
Change in mean Diastolic Blood Pressure
Time frame: between Visit 1 (Week 0) and Visit 4 (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 16 Jul 2010.
- Derived from this study: PubMed 22352122Girerd X, Rosenbaum D, Aoun J; ACTUAL study Investigators. Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study. Blood Press Suppl. 2011 Dec;2:22-9. doi: 10.3109/08037051.2011.633368.
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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.
Nathalie - GENES, MD study director
Sanofi
16 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan - Hydrochlorothiazide in people with Hypertension, run by Sanofi at 16 sites in 16 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 4 inclusion and 16 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 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Algeria, Argentina, Brazil, Colombia, Ecuador and 11 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 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?
Change in mean Systolic Blood Pressure (time frame: between Visit 1 (Week 0) and Visit 4 (Week 10)). 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 NCT00708344, 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 16 Jul 2010.