Efficacy and Safety of Leningrado 5 Association in the Tr... | NCT03814148

Studies
Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension

NCT03814148

Sponsor

EMS

Status

Withdrawn

Last Update Posted

Feb 24, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Arterial Hypertension

Interventions

LENINGRADO 5 association
Natrilix® SR
Natrilix SR Placebo
Leningrado 5 association Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The design of this protocol was rewritten due to regulatory recommendations.

Expanded Access Info

Start Date

Jun 2019Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jan 22, 2019

First Submission Date that Met QC Criteria

Jan 22, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2021

Last Update Posted Date

Feb 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LENINGRADO 5	Experimental	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.	Drug: LENINGRADO 5 association Other: Natrilix SR Placebo
Natrilix® SR	Active Comparator	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.	Drug: Natrilix® SR Other: Leningrado 5 association Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LENINGRADO 5 association	Drug	1 coated sustained-release tablet, oral, once a day.	LENINGRADO 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.		70 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence and severity of adverse events recorded during the study		101 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants aged 18 years or more;
Participants diagnosed with hypertension, 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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases