- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03401580
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
Status
Withdrawn
Conditions
Intervention / Treatment
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:
|
Experimental: Viena II - 190/10
Fixed-dose, 190mg + 10 mg, orally, once daily.
|
once daily
Other Names:
|
Experimental: Viena II - 160/12
Fixed-dose, 160mg + 12 mg, orally, once daily.
|
once daily
Other Names:
|
Experimental: Viena II - 190/12
Fixed-dose, 190mg + 12 mg, orally, once daily.
|
once daily
Other Names:
|
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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMS0317
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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