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Management of Newly Diagnosed and Uncontrolled Hypertension With Fixed-Dose Combination of Perindopril/Amlodipine and Perindopril/Indapamide/Amlodipine

NCT03738761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2020-09-02

No results posted yet for this study

Summary

PRECIOUS Study aims to evaluate the efficacy and safety of therapy with fixed-dose combination (FDC) of perindopril/amlodipine (Amlessa®) and FDC of perindopril/indapamide/amlodipine (Co-Amlessa®) on blood pressure reduction in both previously untreated patients and patients with previous antihypertensive therapy.

Adult patients with AH who are treatment-naïve with systolic blood pressure (SBP) from 150 mmHg or higher AND/OR diastolic blood pressure (DBP) from 95 mmHg or higher (SBP ≥ 150 mm AND/OR DBP ≥ 90 mmHg for patients with type 2 diabetes mellitus ) and uncontrolled patients on mono, dual or triple antihypertensive therapy with systolic blood pressure (SBP) from 140 mmHg or higher AND/OR diastolic blood pressure (DBP) from 90 mmHg or higher (SBP ≥ 140 AND/OR DBP ≥ 85 mmHg for patients with type 2 diabetes mellitus) will be invited to participate in this study.

During 16-week trial, seven study visits are planned. At first study visit physical examination, medical history, BP measurement, electrocardiogram (ECG), laboratory analysis and of Ambulatory Blood Pressure Measurement (ABPM) will be performed. Based on their previous antihypertensive therapy, patients will receive to treatment with either Amlessa® or Co-Amlessa® for the duration of 16 weeks and blood pressure measurements, laboratory investigations and patient interviews will be performed at study follow-up visits to assess the treatment efficacy (proportion of patients reaching normal office blood pressure after 16 weeks of treatment) and safety.

Conditions

Interventions

DRUG

Amlessa®

Fixed-dose combination (FDC) of perindopril/amlodipine, tablets. Strengths: 4mg/5 mg, 8mg/5 mg, 8mg/10 mg.

DRUG

Co-Amlessa®

Fixed-dose combination (FDC) of perindopril/indapamide/amlodipine, tablets. Strengths: 4mg/1.25 mg/5 mg, 8mg/2.5 mg/5 mg, 8mg/2.5 mg/10 mg.

Sponsors & Collaborators

  • Clinres Farmacija d.o.o.

    collaborator INDUSTRY

  • University Medical Centre Ljubljana

    collaborator OTHER

  • KRKA

    lead INDUSTRY

Principal Investigators

  • Jana Brguljan Hitij · University Medical Centre Ljubljana Hospital dr. Peter Držaj

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2019-09-27
Completion
2019-09-27

Countries

  • Armenia
  • Croatia
  • Hungary
  • Poland
  • Russia
  • Serbia
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03738761 on ClinicalTrials.gov