CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Oral zamicastatdrug
Likely dose
Oral zamicastat 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04316143
NCT04316143Phase 2Completed

An Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH)

Bial - Portela C S.A.·interventional·Posted Mar 20, 2020·Updated Oct 15, 2024

In Brief

A Phase 2 clinical trial evaluating Oral zamicastat for Pulmonary Arterial Hypertension. Completed, enrolled 33 participants across 13 sites in 7 countries.

Detailed Summary

This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Italy, Portugal, Spain, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 20, 2020
Enrollment StartJun 3, 2019
Primary CompletionOct 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.3 years ago

Interventions

Oral zamicastatdrug

Tablets for oral administration under fed conditions containing 100 mg of zamicastat