HypertensionPhase 2NCT03401580
Efficacy of Fixed-doses of Antihypertensive and Statin Drugs
A Phase 2 study testing Viena II 160/10, Viena II 190/10 and Viena II 160/12 in people with Hypertension and Dyslipidemia, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Viena II 160/10, Viena II 190/10 and Viena II 160/12
- 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
- Jan 2019to Sep 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of both sexes aged between 18 and 65 years;
- Participants diagnosed with uncontrolled hypertension (stage 1), according VII Brazilian Guideline of Hypertension;
- Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Signed consent.
Who cannot join
- Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
- Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
- Participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL;
- Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension;
- History of congestive heart failure (CHF) functional class III or IV (NYHA);;
- Any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants;
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- Creatine phosphokinase (CPK) levels above the established laboratory normal range;
- Transaminases (ALT and ASL) serum above 2 times the established laboratory normal range;
- Body mass index (BMI) ≥35 kg / m²;
- Immunocompromised participants (eg.: malignancies, patients with Acquired Immunodeficiency Syndrome etc);
- Chronic use of drugs that may interact with the drugs of the study;
- History hypersensitivity to the active ingredients used in the study;
- Pregnancy or risk of pregnancy and lactating patients;
- History of alcohol abuse or illicit drug use;
- Participation in clinical trial in the year prior to this study.
About this study
Official title: Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia
The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.
Read the detailed description
- Fase II, national, multicenter, randomized, double-blind.
- Maximal duration: 8 weeks;
- 04 visits;
- Safety and efficacy evaluation.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Viena II 160/10, Viena II 190/10, Viena II 160/12, Viena II 190/12
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viena II 160/10Drug
Also called Viena II fixed dose
once daily
Viena II 190/10Drug
Also called Viena II fixed dose
once daily
Viena II 160/12Drug
Also called Viena II fixed dose
once daily
Viena II 190/12Drug
Also called Viena II fixed dose
once daily
| Study group | Role | What they receive |
|---|---|---|
| Viena II - 160/10 | Experimental | Fixed-dose, 160mg +10 mg, orally, once daily. Receives: Drug: Viena II 160/10 |
| Viena II - 190/10 | Experimental | Fixed-dose, 190mg + 10 mg, orally, once daily. Receives: Drug: Viena II 190/10 |
| Viena II - 160/12 | Experimental | Fixed-dose, 160mg + 12 mg, orally, once daily. Receives: Drug: Viena II 160/12 |
| Viena II - 190/12 | Experimental | Fixed-dose, 190mg + 12 mg, orally, once daily. Receives: Drug: Viena II 190/12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of systemic blood pressure measured between the first visit and last visit
Measured: 8 weeks
Percentage of reduction of LDL-c between the first visit and the last visit.
Measured: 8 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startJan 2019 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT03401580
- Sponsor's protocol ID
- EMS0317
- Status last verified
- Oct 2019
- First submitted
- 8 Jan 2018
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT03401580
- Acronym / sponsor ID
- EMS0317
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 17 Jan 2018 (actual)
- 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 efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.
Detailed description
- Fase II, national, multicenter, randomized, double-blind.
- Maximal duration: 8 weeks;
- 04 visits;
- Safety and efficacy evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Viena II - 160/10 | Experimental | Drug: Viena II 160/10Fixed-dose, 160mg +10 mg, orally, once daily. |
| Viena II - 190/10 | Experimental | Drug: Viena II 190/10Fixed-dose, 190mg + 10 mg, orally, once daily. |
| Viena II - 160/12 | Experimental | Drug: Viena II 160/12Fixed-dose, 160mg + 12 mg, orally, once daily. |
| Viena II - 190/12 | Experimental | Drug: Viena II 190/12Fixed-dose, 190mg + 12 mg, orally, once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants of both sexes aged between 18 and 65 years;
- Participants diagnosed with uncontrolled hypertension (stage 1), according VII Brazilian Guideline of Hypertension;
- Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Signed consent.
Key exclusion criteria (15 listed)
- Participants with a previous diagnosis of familial hypercholesterolemia (homozygous);
- Concomitant use of angiotensin II receptor blocker (ARB) or inhibitor of angiotensin converting enzyme (ACE);
- Participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL;
- Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension;
- History of congestive heart failure (CHF) functional class III or IV (NYHA);;
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 |
|---|---|---|
| Viena II 160/10Also: Viena II fixed doseonce daily | Drug | Viena II - 160/10 |
| Viena II 190/10Also: Viena II fixed doseonce daily | Drug | Viena II - 190/10 |
| Viena II 160/12Also: Viena II fixed doseonce daily | Drug | Viena II - 160/12 |
| Viena II 190/12Also: Viena II fixed doseonce daily | Drug | Viena II - 190/12 |
Primary outcome
Reduction of systemic blood pressure measured between the first visit and last visit
Time frame: 8 weeks
Percentage of reduction of LDL-c between the first visit and the last visit.
Time frame: 8 weeks
1 secondary outcome
Incidence and severity of adverse events recorded during the study
Time frame: 8 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 16 Oct 2019.
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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 2 study testing Viena II 160/10, Viena II 190/10 and Viena II 160/12 in people with Hypertension and Dyslipidemia, 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 4 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: withdrawn, as of the sponsor's last update on 16 Oct 2019. 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 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 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?
Reduction of systemic blood pressure measured between the first visit and last visit (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 16 Oct 2019.