Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
Phase 3
Withdrawn
- Conditions
- Arterial Hypertension
- Interventions
- Drug: LENINGRADO associationOther: Leningrado association PlaceboOther: Levamlodipine placeboOther: Indapamide SR Placebo
- Registration Number
- NCT03814109
- Lead Sponsor
- EMS
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Participants aged 18 years or more;
- Participants diagnosed with hypertension (mild to moderate), mild to moderate cardiovascular risk, not controlled by monotherapy and/ or lifestyle modification;
Exclusion Criteria
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- BP ≥ 180/110 mmHg;
- Participants with BMI (body mass index) ≥ 40 Kg/m2;
- Previous diagnosis of secondary hypertension;
- History of taget organ damage;
- History of cardiovascular, hepatic and renal disease;
- History of gout, diabetes mellitus and hypokalemia;
- Current medical history of cancer;
- Current smoking;
- History of alcohol abuse or drug use;
- Pregnancy or risk of pregnancy and lactating patients;
- Known allergy or hypersensitivity to the medicines components used during the clinical trial;
- Participation in clinical trial in the year prior to this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LENINGRADO LENINGRADO association The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day. Indapamide Indapamide SR 1.5 MG The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day. Indapamide Leningrado association Placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day. Indapamide Levamlodipine placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet indapamide 1,5 mg, 1 tablet Leningrado association placebo, and 1 tablet levamlodipine placebo, oral, once a day. Levamlodipine Leningrado association Placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day. Levamlodipine Indapamide SR Placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day. LENINGRADO Indapamide SR Placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day. LENINGRADO Levamlodipine placebo The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet Leningrado association,1 tablet indapamide placebo, 1 tablet levamlodipine placebo, oral, once a day. Levamlodipine Levamlodipine 2.5/ 5 mg The study is triple-dummy. Thus, the patient will take 3 tablets, as follow: 1 tablet levamlodipine 2.5/ 5 mg, 1 tablet indapamide placebo, and 1 tablet Leningrado association placebo, oral, once a day.
- Primary Outcome Measures
Name Time Method Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit. 56 days
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events recorded during the study 70 days