Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03814109
Other study ID # EMS0418 - LENINGRADO
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date April 2022
Est. completion date January 2024

Study information

Verified date July 2022
Source EMS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Leningrado association on the treatment of hypertension.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2024
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
LENINGRADO association
1 coated sustained-release tablet, oral, once a day.
Indapamide SR 1.5 MG
1 coated sustained-release tablet, oral, once a day.
Levamlodipine 2.5/ 5 mg
1 tablet, oral, once a day.
Other:
Leningrado association Placebo
1 coated sustained-release tablet, oral, once a day.
Indapamide SR Placebo
1 coated sustained-release tablet, oral, once a day.
Levamlodipine placebo
1 tablet, oral, once a day.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
EMS

Outcome

Type Measure Description Time frame Safety issue
Primary Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit. 56 days
Secondary Incidence and severity of adverse events recorded during the study 70 days
See also
  Status Clinical Trial Phase
Recruiting NCT05684055 - "Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2) N/A
Active, not recruiting NCT05436730 - "Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Not yet recruiting NCT03294070 - Fimasartan Plus Amlodipine on Hemodynamic Parameters and Arterial Stiffness in Patients With Hypertension Phase 4
Recruiting NCT01959997 - Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI Phase 2
Completed NCT00983632 - Selective Vagus Nerve Stimulation in Human N/A
Recruiting NCT06098300 - Effects of Change in Blood Pressure on Retinal Capillary Rarefaction in Patients With Arterial Hypertension
Completed NCT04564118 - A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation
Terminated NCT04677322 - TO ASSESS THE EFFECTIVENESS OF THE INTERVENTION OF THE LOW-SODIUM DIET IN PATIENTS WITH HTA
Completed NCT04278001 - Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement N/A
Withdrawn NCT03047538 - Fixed Combination for Lipid and Blood Pressure Control Phase 4
Completed NCT03046264 - Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis N/A
Completed NCT02620995 - Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction Phase 4
Completed NCT02041832 - Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder N/A
Completed NCT01459120 - Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho N/A
Completed NCT01546181 - Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases
Recruiting NCT01132001 - Ambulatory Versus Home Blood Pressure Measurement N/A
Completed NCT01454583 - Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany N/A
Recruiting NCT03917758 - Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors N/A
Completed NCT03722524 - The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Completed NCT03539627 - Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.