NCT03401580WithdrawnPhase 2
Clinical Trial to Compare the Efficacy and Safety of Fixed-doses of VIENA II in Participants With Hypertension and Dyslipidemia
EMS0 sitesStarted: January 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Percentage of reduction of LDL-c between the first visit and the last visit.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Viena II - 160/10
Experimental
Fixed-dose, 160mg +10 mg, orally, once daily.
Intervention: Viena II 160/10 (Drug)
Viena II - 190/10
Experimental
Fixed-dose, 190mg + 10 mg, orally, once daily.
Intervention: Viena II 190/10 (Drug)
Viena II - 160/12
Experimental
Fixed-dose, 160mg + 12 mg, orally, once daily.
Intervention: Viena II 160/12 (Drug)
Viena II - 190/12
Experimental
Fixed-dose, 190mg + 12 mg, orally, once daily.
Intervention: Viena II 190/12 (Drug)
Outcomes
Primary Outcomes
Percentage of reduction of LDL-c between the first visit and the last visit.
Time Frame: 8 weeks
Reduction of systemic blood pressure measured between the first visit and last visit
Time Frame: 8 weeks
Secondary Outcomes
- Incidence and severity of adverse events recorded during the study(8 weeks)
Investigators
Similar Trials
Completed
Not Applicable
Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)Urinary IncontinenceNCT05287490InMode MD Ltd.31
Completed
Phase 3
Evaluation of the Clinical Efficacy and Safety of Amlodipine 5mg/ Bisoprolol Fumarate 5mg /Perindopril Arginine 5mg Fixed-dose Combination in Capsule and Free Monotherapy at the Same Dose in Patients With Uncontrolled Essential Hypertension.Essential HypertensionNCT05288400Servier150
Completed
Phase 3
Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in HypertensionHypertensionNCT05820880Institut de Recherches Internationales Servier532
Completed
Phase 1
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean VolunteersHealthyNCT05787873Samik Pharmaceutical Co. Ltd.40
Completed
Phase 3
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)Diabetes Mellitus, Type 2NCT00728351Novartis Pharmaceuticals317