Study Stopped
The design of this protocol was rewritten due to regulatory recommendations.
Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2019
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 24, 2021
February 1, 2021
1 year
January 22, 2019
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
70 days
Secondary Outcomes (1)
Incidence and severity of adverse events recorded during the study
101 days
Study Arms (2)
LENINGRADO 5
EXPERIMENTALThe study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.
Natrilix® SR
ACTIVE COMPARATORThe 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.
Interventions
1 coated sustained-release tablet, oral, once a day.
1 coated sustained-release tablet, oral, once a day.
1 coated sustained-release tablet, oral, once a day.
1 coated sustained-release tablet, oral, once a day.
Eligibility Criteria
You may qualify if:
- Participants aged 18 years or more;
- Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification;
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 23, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
February 24, 2021
Record last verified: 2021-02