NCT03809156

Brief Summary

To evaluate the safety and efficacy of first-line combination therapy using riociguat with ambrisentan in patients with Pulmonary Arterial Hypertension (PAH).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

January 9, 2019

Last Update Submit

March 24, 2020

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Vascular resistance

    Change from baseline to month 4 and month 12 in pulmonary vascular resistance (PVR) as assessed by Right Heart Catheterization.

    4 and 12 months

Secondary Outcomes (10)

  • Hemodynamic Variables

    4 and 12 months

  • Echocardiographic parameters

    4 and 12 months

  • RV function

    4 and 12 months

  • NT-PRo-BNP

    4 and 12 Months

  • Exercise capacity

    4 and 12 months

  • +5 more secondary outcomes

Study Arms (1)

Combo Riociguat and Ambrisentan Therapy

EXPERIMENTAL

Riociguat Oral Product and Ambrisentan Oral Product to be given in combination to de novo (untreated) patients.

Drug: Riociguat Oral Product

Interventions

Riociguat Oral ProductDRUG

Dual therapy of Riociguat and Ambrisentan at initiation of treatment.

Also known as: Ambrisentan Oral Product
Combo Riociguat and Ambrisentan Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to initiation of any study mandated procedure;
  • Males or females ≥ 18 years of age i. Women of childbearing potential must have a negative pre-treatment pregnancy test and must use reliable methods of contraception.
  • ii. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or documented surgically or naturally sterile.
  • Patients with symptomatic Functional Class III PAH in the following categories:
  • i. Idiopathic (IPAH) ii. Familial (FPAH) iii. Associated with connective tissue disease iv. Associated with drugs or toxins;
  • PAH diagnosed by right heart catheterization, defined as:
  • i. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg ii. PVR \> 3 mmHg/l/min (Wood units) or \> 240 dyn sec cm-5 iii. Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg;
  • m ≤ 6 Minute Walk Test (6MWT) distance ≤ 480 m

You may not qualify if:

  • PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy;
  • Valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization (i.e., patients with tricuspid or pulmonary insufficiency secondary to PAH can be included);
  • Restrictive lung disease: total lung capacity (TLC) \< 60% of normal predicted value;
  • Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) \< 0.5;
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C;
  • Pregnancy or breast-feeding;
  • Systolic blood pressure \< 95 mmHg;
  • Body weight \< 40 kg;
  • Hemoglobin \> 25% below the lower limit of the normal range;
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal ranges;
  • Renal insufficiency as defined by creatinine clearance \< 30 mL/min or on dialysis
  • Treatment with phosphodiesterase type 5 inhibitors, any prostanoid (excluding acute administration during a catheterization procedure to test vascular reactivity) or with any other PH specific medication;
  • Treatment or planned treatment with calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), CYP2C9 and CYP3A4 inhibitors (i.e., ketoconazole, fluconazole) within 1 week of study start;
  • Treatment or planned treatment with nitrate drugs, short acting nitrate-containing medications, alpha blockers or protease inhibitors (i.e., ritonavir);
  • Known hypersensitivity to ambrisentan, riociguat or any of their excipients;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peter Lougheed Center

Calgary, Alberta, T1Y 6J4, Canada

RECRUITING

Vancouver General Hospital, The Lung Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Naushad Hirani, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naushad Hirani, MD

CONTACT

403 943 4759

Jean Marks, BN

CONTACT

(403) 943 4759jean.marks@ahs.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 18, 2019

Study Start

April 26, 2016

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)