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Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Randomized, Double-blind, Triple-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado Association in the Treatment of Hypertension

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03814109
Enrollment
0
Registered
2019-01-23
Start date
2022-04-30
Completion date
2024-01-31
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension

Keywords

Hypertension

Brief summary

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

Interventions

DRUGLENINGRADO association

1 coated sustained-release tablet, oral, once a day.

DRUGIndapamide SR 1.5 MG

1 coated sustained-release tablet, oral, once a day.

DRUGLevamlodipine 2.5/ 5 mg

1 tablet, oral, once a day.

OTHERLeningrado association Placebo

1 coated sustained-release tablet, oral, once a day.

OTHERIndapamide SR Placebo

1 coated sustained-release tablet, oral, once a day.

OTHERLevamlodipine placebo

1 tablet, oral, once a day.

Sponsors

EMS
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in systolic blood pressure levels, as measured by 24h-ABPM at the initial visit and final visit.56 days

Secondary

MeasureTime frame
Incidence and severity of adverse events recorded during the study70 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026