Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
NCT ID: NCT03814148
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-06-30
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LENINGRADO 5
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.
LENINGRADO 5 association
1 coated sustained-release tablet, oral, once a day.
Natrilix SR Placebo
1 coated sustained-release tablet, oral, once a day.
Natrilix® SR
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo.
Natrilix® SR
1 coated sustained-release tablet, oral, once a day.
Leningrado 5 association Placebo
1 coated sustained-release tablet, oral, once a day.
Interventions
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LENINGRADO 5 association
1 coated sustained-release tablet, oral, once a day.
Natrilix® SR
1 coated sustained-release tablet, oral, once a day.
Natrilix SR Placebo
1 coated sustained-release tablet, oral, once a day.
Leningrado 5 association Placebo
1 coated sustained-release tablet, oral, once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification;
Exclusion Criteria
* BP ≥ 180/110 mmHg;
* Participants with BMI (body mass index) ≥ 40 Kg/m2;
* Previous diagnosis of secondary hypertension;
* History of Target Organ Injury;
* 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.
18 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Other Identifiers
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EMS0618-LENINGRADO 5
Identifier Type: -
Identifier Source: org_study_id
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