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

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

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

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

Conditions
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Hypertension, Dyslipidemia

Intervention / Treatment
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* Drug: Valsartan 160mg + Rosuvastatin 20mg
* Drug: Valsartan 320mg + Rosuvastatin 20mg
* Drug: Diovan® 160mg + Crestor® 20mg
* Drug: Diovan® 320mg + Crestor® 20mg


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan 160mg + Rosuvastatin 20mg<br>Fixed-dose combination of valsartan (160mg) + rosuvastatin (20 mg), oral, once daily. | Drug: Valsartan 160mg + Rosuvastatin 20mg<br>* 1 tablet, oral, a day<br>|
| Experimental: Valsartan 320mg + Rosuvastatin 20mg<br>Fixed-dose combination of valsartan (320 mg) + rosuvastatin (20 mg), oral, once daily. | Drug: Valsartan 320mg + Rosuvastatin 20mg<br>* 1 tablet, oral, a day<br>|
| Active Comparator: Diovan® 160mg + Crestor® 20mg<br>Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily. | Drug: Diovan® 160mg + Crestor® 20mg<br>* Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.<br>* Other names: Valsartan 160mg + Rosuvastatin 20mg;|
| Active Comparator: Diovan® 320mg + Crestor® 20mg<br>Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily. | Drug: Diovan® 320mg + Crestor® 20mg<br>* Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.<br>* Other names: Valsartan 320mg + Rosuvastatin 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of systemic blood pressure measured between the first visit and last visit. |  | 8 weeks | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study. |  | 8 weeks |