Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH

• Conditions: Pulmonary arterial hypertension; MedDRA version: 9.1Level: LLTClassification code 10036727Term: Primary pulmonary hypertension

• Registration Number: EUCTR2007-003975-38-CZ
• Lead Sponsor: Ergonex Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1.Female and male patients of any racial origin with PAH (WHO classification II-IV)
2.On stable treatment with best supportive care with anticoagulant drugs, diuretics, cardiac glycosides, supplemental oxygen and calcium channels blockers, adjusted to the individual need of the respective patient. Specific PAH mono-therapy (or combination-therapy not exceeding two PAH specific drugs) with either endothelin receptor antagonists or phosphodiesterase type 5 inhibitors or non-parenteral prostanoids (i.e. inhaled, oral, s.c.) is allowed (pre-treated patients) but not mandatory (treatment naive patients). Patients already on PAH specific drugs must be receiving a stable dose of the medication for at least 3 months
3.Having fulfilled his/her 18th birthday on Day 1 of the study but not older than 80 years (up to the patient’s 81st birthday).
4.PAH due to idiopathic pulmonary arterial hypertension or connective tissue disease associated PAH
5.Cardiac catheterisation 4 weeks prior to screening or at screening with PAH, specifically PAPm >=25 mmHg (at rest), Pulmonary capillary wedge pressure (PCWP) <=16 mmHg, pulmonary vascular resistance >=500 dyn x sec x cm-5. Echocardiogram at screening consistent with PAH, specifically evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis
6.Six minute walk distance above 150 m
7.Receiving conventional PAH therapy, stable for one month.
8.Presentation of negative test results in regard to HIV, Hepatitis C/B, not older than 4 weeks.
9.Able to understand and willing to sign the Informed Consent Form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy and/or lactation
2.PAH of any cause other than permitted in the entry criteria
3.Contraindication for heart catheterisation
4.Any change in disease-targeted therapy within the last month before screening
5.Patients requiring intravenous prostanoid therapy within 3 months prior to study start
6.Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
7.Known intolerance to Terguride
8.Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
9.History or suspicion of inability to cooperate adequately .
10.Cancer or other malign haematological disease
11.Pulmonary Hypertension caused by left heart disease
12.Pulmonary Arterial Hypertension associated with congenital heart disease (PAH-CHD)
13.Pulmonary Arterial Hypertension associated with human immunodeficiency virus infection (PAH-HIV)
14.Portopulmonary Hypertension (PPHT)
15.CTEPH Chronic Thromboembolic Pulmonary Hypertension
16.Pulmonary Hypertension associated with other diseases (i.e. Sarcoidosis, Histiocytosis, etc)
17.Pulmonary Hypertension associated with other chronic lung diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified