Essential Arterial HypertensionPhase 3NCT02521233
Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
A Phase 3 study testing Candesartan + Chlorthalidone (8mg+12,5mg), Candesartan + Chlorthalidone (8 mg + 25 mg) and losartan+hydrochlorothiazide in people with Essential Arterial Hypertension, run by EMS.
Trial summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Essential Arterial Hypertension
- What is being tested?
- Candesartan + Chlorthalidone (8mg+12,5mg), Candesartan + Chlorthalidone (8 mg + 25 mg) and losartan+hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Aug 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Consent of the patient;
- Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.
- Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements
Who cannot join
- Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
- Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
- Morbid obesity or immunocompromised patients;
- Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
- Participants who do not have the two upper limbs;
- Participants with important electrocardiographic changes;
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- Creatinine clearance - less than 60 mL /min;
- History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
- Microalbuminuria in urine sample greater than 30 mg/g;
- Patients with history of hypersensitivity to any of the formula compounds;
- Pregnancy or risk of pregnancy and lactating patients;
- Participation in clinical trial in the year prior to this study.
About this study
Official title: Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
- Conditions
- Essential Arterial Hypertension
- Being tested
- Candesartan + Chlorthalidone (8mg+12,5mg), Candesartan + Chlorthalidone (8 mg + 25 mg), losartan+hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan + Chlorthalidone (8mg+12,5mg)Drug
Also called Candesartan + Chlorthalidone
Candesartan + Chlorthalidone (8 mg + 25 mg)Drug
Also called Candesartan + Chlorthalidone
losartan+hydrochlorothiazideDrug
Also called Hyzaar ®
| Study group | Role | What they receive |
|---|---|---|
| Test 1: Candesartan + Chlorthalidone | Experimental | The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning. Receives: Drug: Candesartan + Chlorthalidone (8mg+12,5mg) |
| Test 2: Candesartan + Chlorthalidone | Experimental | The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning. Receives: Drug: Candesartan + Chlorthalidone (8 mg + 25 mg) |
| Comparator: losartan+hydrochlorothiazide (Hyzaar®) | Active comparator | he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning. Receives: Drug: losartan+hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Measured: 60 days
Secondary outcomes (1)
Safety will be evaluated by the occurrences of adverse events.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startNov 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by EMSThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521233
- Sponsor's protocol ID
- CACEMS0514OR-III
- Status last verified
- Jan 2017
- First submitted
- 10 Aug 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
- ClinicalTrials.gov ID
- NCT02521233
- Acronym / sponsor ID
- CACEMS0514OR-III
- Conditions
- Essential Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 13 Aug 2015 (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 purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1: Candesartan + Chlorthalidone | Experimental | Drug: Candesartan + Chlorthalidone (8mg+12,5mg)The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning. |
| Test 2: Candesartan + Chlorthalidone | Experimental | Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning. |
| Comparator: losartan+hydrochlorothiazide (Hyzaar®) | Active comparator | Drug: losartan+hydrochlorothiazidehe patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Consent of the patient;
- Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.
- Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements
Key exclusion criteria (12 listed)
- Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
- Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
- Morbid obesity or immunocompromised patients;
- Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
- Participants who do not have the two upper limbs;
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 |
|---|---|---|
| Candesartan + Chlorthalidone (8mg+12,5mg)Also: Candesartan + Chlorthalidone | Drug | Test 1: Candesartan + Chlorthalidone |
| Candesartan + Chlorthalidone (8 mg + 25 mg)Also: Candesartan + Chlorthalidone | Drug | Test 2: Candesartan + Chlorthalidone |
| losartan+hydrochlorothiazideAlso: Hyzaar ® | Drug | Comparator: losartan+hydrochlorothiazide (Hyzaar®) |
Primary outcome
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
Time frame: 60 days
1 secondary outcome
Safety will be evaluated by the occurrences of adverse events.
Time frame: 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan + Chlorthalidone (8mg+12,5mg), Candesartan + Chlorthalidone (8 mg + 25 mg) and losartan+hydrochlorothiazide in people with Essential Arterial Hypertension, run by EMS.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 19 Jan 2017. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal (time frame: 60 days). 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 Jan 2017.