Right ventriculAr reverse reModeling and hemodynamic improvement after add-on combination therapy (ambriSentan/PDE-5i) in PAH patientS (RAMSES)

Right ventriculAr reverse reModeling and hemodynamic improvement after add-on combination therapy (ambriSentan/PDE-5i) in PAH patientS (RAMSES) - RAMSES

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004806-32-IT

Enrollment

Registered

2021-05-24

Start date

2019-03-02

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

patients with pulmonary arterial hypertention MedDRA version: 21.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: na Product Name: Volibris Product Code: [EU/1/08/451/004] Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 177036-94-1 Current Sponsor code: NA Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: NA Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Main Objective: NA;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Italy

Contacts

Public ContactDott. Stefano Ghio

IPHNET

s.ghio@smatteo.pv.it0382503460

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026