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Efficacy of Fixed-doses of Antihypertensive and Statin Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401580
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : January 17, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
EMS

Study Description
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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
Hypertension Dyslipidemia 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
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Viena II - 160/10
Fixed-dose, 160mg +10 mg, orally, once daily.
 Drug: Viena II 160/10
once daily
Other Name: 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 Name: 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 Name: 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 Name: Viena II fixed dose


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of systemic blood pressure measured between the first visit and last visit [ Time Frame: 8 weeks ]
  2. Percentage of reduction of LDL-c between the first visit and the last visit. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events recorded during the study [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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No Contacts or Locations Provided
More Information
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03401580    
Other Study ID Numbers: EMS0317
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases