HypertensionPhase 4COSIMA2NCT00500604
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
A Phase 4 study testing Irbesartan/hydrochlorothiazide, Valsartan/hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension, run by Sanofi at 14 sites in 14 countries.
Trial summary
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan/hydrochlorothiazide, Valsartan/hydrochlorothiazide and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,617 participants
- Where
- 14 sitesin 14 countries
- Study dates
- Jul 2007to Jan 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established essential hypertension, untreated or treated but uncontrolled with treatment:
- Office SBP ≥ 160 mmHg for untreated patients
- Office SBP ≥ 140 mmHg for patients already treated with an antihypertensive drug.
- Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
- ACE inhibitor / calcium channel blocker
- Beta blocker / calcium channel blocker
- Beta blocker / low dose diuretic
- ACE inhibitor / low dose diuretic
Who cannot join
- SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
- Known or suspected causes of secondary hypertension
- Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
- Type 1 diabetes mellitus
- Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
- 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
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- Known contraindications to any of the study drugs
- Concomitant use of any other antihypertensive treatment
- Use of any of the investigational products for this study within the 3 months prior to the study
- Inability to obtain a valid HBPM recording i.e., obesity, arm circumference > 32 cm or arrhythmia
- Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
- Pregnant or breast-feeding women
- 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
- 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
14 sites in 14 countries.
14 sites in 14 countries
About this study
Official title: A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.
The secondary objectives are:
- To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
- To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
- To compare the difference in mean SBP evaluated by HBPM at week 16
- To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
- To determine the incidence and severity of adverse events
- Conditions
- Hypertension
- Being tested
- Irbesartan/hydrochlorothiazide, Valsartan/hydrochlorothiazide, 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
150/12.5mg tablet and 300/12.5mg tablet
Valsartan/hydrochlorothiazideDrug
80/12.5mg tablet and 160/12.5mg tablet
HydrochlorothiazideDrug
12.5 mg administered orally, once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | * period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
* period 2: One 150/12.5mg tablet every morning for 8 weeks.
* period 3: One 300/12.5mg tablet every morning for 8 weeks.
* period 4: Two 150/12.5mg tablets every morning for 8 weeks. Receives: Drug: Irbesartan/hydrochlorothiazide; Drug: Hydrochlorothiazide |
| B | Active comparator | * period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks
* period 2: One 80/12.5mg tablet every morning for 8 weeks.
* period 3: One 160/12.5mg tablet every morning for 8 weeks.
* period 4: Two 80/12.5mg tablets every morning for 8 weeks. Receives: Drug: Valsartan/hydrochlorothiazide; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean SBP as measured by HBPM
Measured: From week 0 to week 24
Secondary outcomes (8)
Reduction in mean DBP as measured by HBPM
Measured: From week 0 to weeks 16 and 24
Reduction in mean morning and evening SBP as measured by HBPM
Measured: From week 0 to weeks 16 and 24
Reduction in mean morning and evening DBP as measured by HBPM
Measured: From week 0 to weeks 16 and 24
Reduction in mean SBP and mean DBP evaluated at the doctor's office
Measured: From week 0 to weeks 16 and 24
Number of normalised patients as measured by HBPM
Measured: From week 0 to weeks 16 and 24
Number of normalised patients evaluated at the doctor's office
Measured: From week 0 to weeks 16 and 24
Reduction in mean SBP as measured by HBPM
Measured: From week 0 to week 16
Adverse events, vital signs, laboratory tests
Measured: From visit 1 to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJul 2007
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benedict Blayney, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500604
- Sponsor's protocol ID
- IRBEH_R_02584
- Acronym
- COSIMA2
- Status last verified
- Jul 2010
- First submitted
- 11 Jul 2007
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy of Irbesartan/Hydrochlorothiazide 300/25 mg Versus Valsartan/Hydrochlorothiazide 160/25 mg Using Home Blood Pressure Monitoring in the Treatment of Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00500604
- Acronym / sponsor ID
- COSIMA2 / IRBEH_R_02584
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,617 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jul 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.
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.
The secondary objectives are:
- To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24
- To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24
- To compare the difference in mean SBP evaluated by HBPM at week 16
- To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24
- 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 |
|---|---|---|
| A | Experimental | Drug: Irbesartan/hydrochlorothiazide, Drug: Hydrochlorothiazide* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks * period 2: One 150/12.5mg tablet every morning for 8 weeks. * period 3: One 300/12.5mg tablet every morning for 8 weeks. * period 4: Two 150/12.5mg tablets every morning for 8 weeks. |
| B | Active comparator | Drug: Valsartan/hydrochlorothiazide, Drug: Hydrochlorothiazide* period 1: Hydrochlorothiazide 12.5 mg for 3-5 weeks * period 2: One 80/12.5mg tablet every morning for 8 weeks. * period 3: One 160/12.5mg tablet every morning for 8 weeks. * period 4: Two 80/12.5mg tablets every morning for 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Established essential hypertension, untreated or treated but uncontrolled with treatment:
- Previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs:
Key exclusion criteria (14 listed)
- SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg evaluated at doctor's office at Visit 1
- Known or suspected causes of secondary hypertension
- Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney
- Type 1 diabetes mellitus
- Significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the Investigator to make participation in the study not in the best interest of the subject
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/hydrochlorothiazide150/12.5mg tablet and 300/12.5mg tablet | Drug | A |
| Valsartan/hydrochlorothiazide80/12.5mg tablet and 160/12.5mg tablet | Drug | B |
| Hydrochlorothiazide12.5 mg administered orally, once daily in the morning | Drug | A, B |
Primary outcome
Reduction in mean SBP as measured by HBPM
Time frame: From week 0 to week 24
8 secondary outcomes
Reduction in mean DBP as measured by HBPM
Time frame: From week 0 to weeks 16 and 24
Reduction in mean morning and evening SBP as measured by HBPM
Time frame: From week 0 to weeks 16 and 24
Reduction in mean morning and evening DBP as measured by HBPM
Time frame: From week 0 to weeks 16 and 24
Reduction in mean SBP and mean DBP evaluated at the doctor's office
Time frame: From week 0 to weeks 16 and 24
Number of normalised patients as measured by HBPM
Time frame: From week 0 to weeks 16 and 24
Number of normalised patients evaluated at the doctor's office
Time frame: From week 0 to weeks 16 and 24
Reduction in mean SBP as measured by HBPM
Time frame: From week 0 to week 16
Adverse events, vital signs, laboratory tests
Time frame: From visit 1 to end of study
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 19 Jul 2010.
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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.
Benedict Blayney study director
Sanofi
14 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan/hydrochlorothiazide, Valsartan/hydrochlorothiazide and Hydrochlorothiazide in people with Hypertension, run by Sanofi at 14 sites in 14 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 14 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 19 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 14 sites in Egypt, Hong Kong, India, Indonesia, Malaysia and 9 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?
Reduction in mean SBP as measured by HBPM (time frame: From week 0 to week 24). 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 19 Jul 2010.