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

Phase 3

Withdrawn

• Conditions: Hypertension; Dyslipidemia
• Interventions: Drug: Diovan® 320mg + Crestor® 20mg; Drug: Valsartan 320mg + Rosuvastatin 20mg; Drug: Diovan® 160mg + Crestor® 20mg; Drug: Valsartan 160mg + Rosuvastatin 20mg

• Registration Number: NCT02662894
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

* Open-label,randomized, multicenter;

* Maximal experiment duration: 8 weeks;

* 04 visits;

* Safety and efficacy evaluation

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2019-10
• Primary Completion: 2020-09
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diovan® 320mg + Crestor® 20mg	Diovan® 320mg + Crestor® 20mg	Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Valsartan 320mg + Rosuvastatin 20mg	Valsartan 320mg + Rosuvastatin 20mg	Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily.
Diovan® 160mg + Crestor® 20mg	Diovan® 160mg + Crestor® 20mg	Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Valsartan 160mg + Rosuvastatin 20mg	Valsartan 160mg + Rosuvastatin 20mg	Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who reach the goal of LDL-C according to intermediate risk rating ( LDLc < 100mg / dL ) and high risk ( LDLc < 70 mg / dL ) .	8 weeks
Reduction of systemic blood pressure measured between the first visit and last visit.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.	8 weeks