Clinical trial NCT02662894: Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
Official title: Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension
Dyslipidemia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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;

Primary outcomes:
measure: Reduction of systemic blood pressure measured between the first visit and last visit.
timeFrame: 8 weeks
measure: 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 ) .
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded after the signing of the Informed Consent ( IC) and until the end of the study.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: