Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02662894
Eligibility Criteria:
Inclusion Criteria:
* 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) .
Exclusion Criteria:
* 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);
* 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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02662894
Study Brief:
Protocol Section:
NCT02662894