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Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

Sponsor
EMS (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03401580
Collaborator
(none)
0
Enrollment
4
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Viena II 160/10
  • Drug: Viena II 190/10
  • Drug: Viena II 160/12
  • Drug: Viena II 190/12
 Phase 2

Detailed Description

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

  • Maximal duration: 8 weeks;

  • 04 visits;

  • Safety and efficacy evaluation.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Viena II - 160/10

Fixed-dose, 160mg +10 mg, orally, once daily.

Drug: Viena II 160/10
once daily
Other Names:
  • Viena II fixed dose

    		•
    Experimental: Viena II - 190/10

    Fixed-dose, 190mg + 10 mg, orally, once daily.

    Drug: Viena II 190/10
    once daily
    Other Names:
  • Viena II fixed dose

    		•
    Experimental: Viena II - 160/12

    Fixed-dose, 160mg + 12 mg, orally, once daily.

    Drug: Viena II 160/12
    once daily
    Other Names:
  • Viena II fixed dose

    		•
    Experimental: Viena II - 190/12

    Fixed-dose, 190mg + 12 mg, orally, once daily.

    Drug: Viena II 190/12
    once daily
    Other Names:
  • Viena II fixed dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of systemic blood pressure measured between the first visit and last visit [8 weeks]

    2. Percentage of reduction of LDL-c between the first visit and the last visit. [8 weeks]

    Secondary Outcome Measures

    1. Incidence and severity of adverse events recorded during the study [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT03401580
    Other Study ID Numbers:
    • EMS0317
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Oct 16, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Dyslipidemias

    Study Results

    No Results Posted as of Oct 16, 2019