NCT03924154

A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)

A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH).

Detailed description

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH). Study participation for each patient will last approximately 3 months and will consist of a screening period (up to 28 days in duration), a baseline period (day 1, pre-dose), a 6-week treatment period, and a 2-week follow-up period. The study will enroll approximately 36 patients at approximately 20 centers across the United States and Canada.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	RVT-1201	RVT-1201 600 mg immediate-release tablet
DRUG	Placebo	Inactive pill manufactured to mimic RVT-1201 600 mg immediate-release tablet

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2019-04-23
• Last updated: 2020-03-09

Locations

23 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study