Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

October 14, 2019 updated by: EMS

Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia

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

Study Overview

Detailed Description

  • Fase II, national, multicenter, randomized, double-blind.
  • Maximal duration: 8 weeks;
  • 04 visits;
  • Safety and efficacy evaluation.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viena II - 160/10
Fixed-dose, 160mg +10 mg, orally, once daily.
once daily
Other Names:
  • Viena II fixed dose
Experimental: Viena II - 190/10
Fixed-dose, 190mg + 10 mg, orally, once daily.
once daily
Other Names:
  • Viena II fixed dose
Experimental: Viena II - 160/12
Fixed-dose, 160mg + 12 mg, orally, once daily.
once daily
Other Names:
  • Viena II fixed dose
Experimental: Viena II - 190/12
Fixed-dose, 190mg + 12 mg, orally, once daily.
once daily
Other Names:
  • Viena II fixed dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of systemic blood pressure measured between the first visit and last visit
Time Frame: 8 weeks
8 weeks
Percentage of reduction of LDL-c between the first visit and the last visit.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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