Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Phase 2

Withdrawn

• Conditions: Hypertension; Dyslipidemia
• Interventions: Drug: Viena II 160/12; Drug: Viena II 190/10; Drug: Viena II 190/12; Drug: Viena II 160/10

• Registration Number: NCT03401580
• Lead Sponsor: EMS

Brief Summary

The purpose of this study is to evaluate the efficacy of different fixed-dose combination of Viena II in treatment of hypertension and dyslipidemia.

Detailed Description

* Fase II, national, multicenter, randomized, double-blind.

* Maximal duration: 8 weeks;

* 04 visits;

* Safety and efficacy evaluation.

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Study Start: 2019-01
• Primary Completion: 2019-07
• Study Completion: 2019-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16

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• Status: WITHDRAWN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 (stage 1), according VII Brazilian Guideline of Hypertension;
• Participants diagnosed with dyslipidemia, according to the V Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
• Signed consent.

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 total cholesterol (TC) above 500 mg / dL or triglyceride (TG) above 500 mg / dL;
• Participants with hypertension (stage 2 or 3) according VII Brazilian Guideline of Hypertension;
• 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;
• History hypersensitivity to the active ingredients used in the study;
• Pregnancy or risk of pregnancy and lactating patients;
• History of alcohol abuse or illicit drug use;
• Participation in clinical trial in the year prior to this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viena II - 160/12	Viena II 160/12	Fixed-dose, 160mg + 12 mg, orally, once daily.
Viena II - 190/10	Viena II 190/10	Fixed-dose, 190mg + 10 mg, orally, once daily.
Viena II - 190/12	Viena II 190/12	Fixed-dose, 190mg + 12 mg, orally, once daily.
Viena II - 160/10	Viena II 160/10	Fixed-dose, 160mg +10 mg, orally, once daily.

Primary Outcome Measures

Name	Time	Method
Percentage of reduction of LDL-c between the first visit and the last visit.	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 during the study	8 weeks