A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (LEPHT)

Bayer

Status and phase: Completed; Phase 2

Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary

Treatments: Drug: Riociguat (Adempas, BAY63-2521); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01065454

2023-507001-34-00 (Other Identifier)

14308

2009-015878-35 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Full description

Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

Enrollment: 202 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy

Exclusion criteria

• Types of pulmonary hypertension other than group 2.1 of Dana Point Classification

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

202 participants in 4 patient groups, including a placebo group

Riociguat (Adempas, BAY63-2521) up to 2 mg

Experimental group

Description:

Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Riociguat (Adempas, BAY63-2521) up to 1 mg

Experimental group

Description:

Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Riociguat (Adempas, BAY63-2521) fixed 0.5 mg

Experimental group

Description:

Participants received riociguat 0.5 mg tid (fixed dose).

Treatment:

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Drug: Riociguat (Adempas, BAY63-2521)

Placebo

Placebo Comparator group

Description:

Participants received placebo tid.

Treatment:

Drug: Placebo