NCT02007629 (RESPITE) is a Phase 3 clinical trial of Riociguat (Adempas, BAY63-2521) in Hypertension, Pulmonary, sponsored by Bayer.

Who is sponsoring NCT02007629?

NCT02007629 is sponsored by Bayer.

What drugs are being tested in NCT02007629?

Interventions in NCT02007629: Riociguat (Adempas, BAY63-2521).

What condition does NCT02007629 study?

NCT02007629 studies Hypertension, Pulmonary.

Is NCT02007629 still recruiting?

NCT02007629 is currently completed. Last updated 21 February 2019.

Last reviewed 2019-02-21 · How we verify

NCT02007629: RESPITE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

Completed Phase 3 Last updated 21 February 2019

What this trial tests

Phase 3 trial testing Riociguat (Adempas, BAY63-2521) in Hypertension, Pulmonary in 61 participants. Completed in 29 December 2016.

Timeline

18 February 2014

Primary endpoint
29 December 2016

29 December 2016

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	18 February 2014
Primary completion	29 December 2016
Estimated completion	29 December 2016
Sites	27 locations across France, Italy, Belgium, United Kingdom, Germany, Canada, Switzerland, United States

Drugs / interventions tested

Riociguat (Adempas, BAY63-2521) — full drug profile →

Conditions studied

Hypertension, Pulmonary — all drugs for Hypertension, Pulmonary →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 75, any sex, with Hypertension, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat. Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Pulmonary Hypertension.
Hoeper MM, Ghofrani HA, Grünig E, Klose H, et al · · 2017 · cited 123× · PMID 28241922 · DOI 10.3238/arztebl.2017.0073
cGMP: a unique 2nd messenger molecule - recent developments in cGMP research and development.
Friebe A, Sandner P, Schmidtko A. · · 2020 · cited 102× · PMID 31853617 · DOI 10.1007/s00210-019-01779-z
RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors.
Hoeper MM, Simonneau G, Corris PA, Ghofrani HA, et al · · 2017 · cited 97× · PMID 28889107 · DOI 10.1183/13993003.02425-2016
Riociguat: Clinical research and evolving role in therapy.
Klinger JR, Chakinala MM, Langleben D, Rosenkranz S, et al · · 2021 · cited 27× · PMID 33242341 · DOI 10.1111/bcp.14676
First-in-child use of the oral soluble guanylate cyclase stimulator riociguat in pulmonary arterial hypertension.
Spreemann T, Bertram H, Happel CM, Kozlik-Feldmann R, et al · · 2018 · cited 22× · PMID 29099661 · DOI 10.1177/2045893217743123
A focus on riociguat in the treatment of pulmonary arterial hypertension.
Toxvig AK, Wehland M, Grimm D, Infanger M, et al · · 2019 · cited 15× · PMID 31206240 · DOI 10.1111/bcpt.13272
Guanylate cyclase stimulators for pulmonary hypertension.
Wardle AJ, Seager MJ, Wardle R, Tulloh RM, et al · · 2016 · cited 15× · PMID 27482837 · DOI 10.1002/14651858.cd011205.pub2
Rationale and study design of RESPITE: An open-label, phase 3b study of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors.
Hoeper MM, Klinger JR, Benza RL, Simonneau G, et al · · 2017 · cited 13× · PMID 27887774 · DOI 10.1016/j.rmed.2016.11.001

Verify or expand the search:

Other trials of Riociguat (Adempas, BAY63-2521)

Trials testing the same drug.

NCT04813926 — A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patien · completed
NCT02891850 — Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy · Phase 4 · completed
NCT02562235 — Riociguat in Children With Pulmonary Arterial Hypertension (PAH) · Phase 3 · active not recruiting
NCT02545465 — A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic · completed
NCT02283762 — Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis · Phase 2 · completed

Other recruiting trials for Hypertension, Pulmonary

Currently open trials in the same condition.

NCT07087613 — Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · recruiting
NCT06814145 — Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) · Phase 2 · recruiting
NCT05867914 — Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD · NA · active not recruiting
NCT05719415 — Functional Pulmonary Capillary Surface Area in BPA for CTEPH · NA · recruiting
NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting

Other Bayer trials

Trials by the same sponsor.

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NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02007629 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 21 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02007629.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing