Status:
WITHDRAWN
Efficacy of Fixed-doses of Antihypertensive and Statin Drugs
Lead Sponsor:
EMS
Conditions:
Hypertension
Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
* Fase II, national, multicenter, randomized, double-blind. * Maximal duration: 8 weeks; * 04 visits; * Safety and efficacy evaluation.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03401580
Start Date
January 1 2019
End Date
September 1 2019
Last Update
October 16 2019
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