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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: Valsartan 320mg + Rosuvastatin 20mg; Drug: Valsartan 160mg + Rosuvastatin 20mg; Drug: Diovan® 160mg + Crestor® 20mg; Drug: Diovan® 320mg + Crestor® 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02662894

EMS0815

Details and patient eligibility

About

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

Full description

• Open-label,randomized, multicenter;
• Maximal experiment duration: 8 weeks;
• 04 visits;
• Safety and efficacy evaluation

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Valsartan 160mg + Rosuvastatin 20mg

Experimental group

Description:

Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.

Treatment:

Drug: Valsartan 160mg + Rosuvastatin 20mg

Valsartan 320mg + Rosuvastatin 20mg

Experimental group

Description:

Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.

Treatment:

Drug: Valsartan 320mg + Rosuvastatin 20mg

Diovan® 160mg + Crestor® 20mg

Active Comparator group

Description:

Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.

Treatment:

Drug: Diovan® 160mg + Crestor® 20mg

Diovan® 320mg + Crestor® 20mg

Active Comparator group

Description:

Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.

Treatment:

Drug: Diovan® 320mg + Crestor® 20mg