Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Rosuvastatin Calcium; Valsartan

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;