Dyslipidemia, Hypertension
Conditions
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
Interventions
DRUGValsartan 160mg + Rosuvastatin 20mg
1 tablet, oral, a day
DRUGValsartan 320mg + Rosuvastatin 20mg
1 tablet, oral, a day
DRUGDiovan® 160mg + Crestor® 20mg
Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
DRUGDiovan® 320mg + Crestor® 20mg
Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed