HypertensionPhase 3NCT02662894
Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
A Phase 3 study testing Valsartan 160mg + Rosuvastatin 20mg, Valsartan 320mg + Rosuvastatin 20mg and Diovan® 160mg + Crestor® 20mg in people with Hypertension and Dyslipidemia, run by EMS.
Trial summary
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components 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?
- Valsartan 160mg + Rosuvastatin 20mg, Valsartan 320mg + Rosuvastatin 20mg and Diovan® 160mg + Crestor® 20mg
- 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
- Oct 2019to Dec 2020
- 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
- Participants of both sexes aged between 18 and 65 years;
- Participants diagnosed with uncontrolled hypertension;
- Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .
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 isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;
- participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
- research participants with postural hypotension (SBP decrease ≥20 mmHg or DBP ≥10 mmHg in orthostatic position in relation to the sitting position);
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- 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;
- 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;
- Patients on concomitant lipid-lowering therapy;
- History hypersensitivity to the active ingredients used in the study;
- Participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;
- History of alcohol abuse or illicit drug use;
- Adherence to uniformization medication <80%;
- Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
About this study
Official title: Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.
Read the detailed description
- Open-label,randomized, multicenter;
- Maximal experiment duration: 8 weeks;
- 04 visits;
- Safety and efficacy evaluation
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Valsartan 160mg + Rosuvastatin 20mg, Valsartan 320mg + Rosuvastatin 20mg, Diovan® 160mg + Crestor® 20mg, Diovan® 320mg + Crestor® 20mg
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 160mg + Rosuvastatin 20mgDrug
1 tablet, oral, a day
Valsartan 320mg + Rosuvastatin 20mgDrug
1 tablet, oral, a day
Diovan® 160mg + Crestor® 20mgDrug
Also called Valsartan 160mg + Rosuvastatin 20mg
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Diovan® 320mg + Crestor® 20mgDrug
Also called Valsartan 320mg + Rosuvastatin 20mg
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan 160mg + Rosuvastatin 20mg | Experimental | Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily. Receives: Drug: Valsartan 160mg + Rosuvastatin 20mg |
| Valsartan 320mg + Rosuvastatin 20mg | Experimental | Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily. Receives: Drug: Valsartan 320mg + Rosuvastatin 20mg |
| Diovan® 160mg + Crestor® 20mg | Active comparator | Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily. Receives: Drug: Diovan® 160mg + Crestor® 20mg |
| Diovan® 320mg + Crestor® 20mg | Active comparator | Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily. Receives: Drug: Diovan® 320mg + Crestor® 20mg |
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 participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .
Measured: 8 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of 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 posted26 Jan 2016 (estimated)
- Study startOct 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT02662894
- Sponsor's protocol ID
- EMS0815
- Status last verified
- Feb 2021
- First submitted
- 23 Nov 2015
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT02662894
- Acronym / sponsor ID
- EMS0815
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jan 2016 (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.
Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.
Detailed description
- Open-label,randomized, multicenter;
- Maximal experiment duration: 8 weeks;
- 04 visits;
- Safety and efficacy evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Valsartan 160mg + Rosuvastatin 20mg | Experimental | Drug: Valsartan 160mg + Rosuvastatin 20mgFixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily. |
| Valsartan 320mg + Rosuvastatin 20mg | Experimental | Drug: Valsartan 320mg + Rosuvastatin 20mgFixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily. |
| Diovan® 160mg + Crestor® 20mg | Active comparator | Drug: Diovan® 160mg + Crestor® 20mgTake together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily. |
| Diovan® 320mg + Crestor® 20mg | Active comparator | Drug: Diovan® 320mg + Crestor® 20mgTake together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, 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;
- Participants with intermediate and high risk dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent and Informed ( IC) .
Key exclusion criteria (19 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 isolated hypertriglyceridemia (TG ≥150 mg / dL) according to V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- research participants with total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 400 mg / dL;
- participants with systolic blood pressure ≥180 mmHg or diastolic ≥110 mmHg;
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 |
|---|---|---|
| Valsartan 160mg + Rosuvastatin 20mg1 tablet, oral, a day | Drug | Valsartan 160mg + Rosuvastatin 20mg |
| Valsartan 320mg + Rosuvastatin 20mg1 tablet, oral, a day | Drug | Valsartan 320mg + Rosuvastatin 20mg |
| Diovan® 160mg + Crestor® 20mgAlso: Valsartan 160mg + Rosuvastatin 20mgTake together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily. | Drug | Diovan® 160mg + Crestor® 20mg |
| Diovan® 320mg + Crestor® 20mgAlso: Valsartan 320mg + Rosuvastatin 20mgTake together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily. | Drug | Diovan® 320mg + Crestor® 20mg |
Primary outcome
Reduction of systemic blood pressure measured between the first visit and last visit.
Time frame: 8 weeks
Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .
Time frame: 8 weeks
1 secondary outcome
Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of 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 24 Feb 2021.
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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 Valsartan 160mg + Rosuvastatin 20mg, Valsartan 320mg + Rosuvastatin 20mg and Diovan® 160mg + Crestor® 20mg 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 19 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 24 Feb 2021. 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?
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 24 Feb 2021.