Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

• Status: Withdrawn
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS

Criteria

Inclusion Criteria:

• 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 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 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.