EUCTR2004-003870-27-GR
Active, not recruiting
Phase 1
A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute stroke - ENOS
niversity of Nottingham, ResearchHead of research grants and contractsInnovation Services0 sites4,011 target enrollmentSeptember 20, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- niversity of Nottingham, ResearchHead of research grants and contractsInnovation Services
- Enrollment
- 4011
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Adult (age \> 18 years).
- •b) Clinical stroke syndrome with limb weakness lasting at least 1 hour (i.e. not likely to be a
- •transient ischaemic attack).
- •c) Residual limb weakness at the time of enrolment (SSS Arm \<6 and/or Leg \<6, appendix C).
- •d) Onset \< 48 hours. If the time of onset is unknown, apply the time when the patient was last
- •known to be well. \[This timeframe covers the period of maximum uncertainty over altering
- •blood pressure and should permit the vast majority of otherwise eligible patients to be
- •e) Conscious (Glasgow Coma Scale \> 8\).
- •f) Systolic blood pressure in range 140 mmHg to 220 mmHg inclusive on the basis of at least
- •one of the three baseline pre\-randomisation measures.
Exclusion Criteria
- •a) Definite need for nitrate therapy: e.g. concurrent myocardial infarction, unstable angina, left
- •ventricular failure. Patients admitted on nitrates for the management of stable angina may
- •stop these for the 7 day trial treatment period.
- •b) Contraindication to nitrate therapy: e.g. hypersensitivity to nitrates, dehydration,
- •hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac
- •tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed\-angle
- •glaucoma, sildenafil (Viagra) or related drug, within 24 hours.
- •c) Definite need for pre\-stroke antihypertensive, anti\-anginal or anti\-heart failure medication:
- •e.g. concurrent angina, heart failure.
- •d) Definite need for new antihypertensive, anti\-anginal or anti\-heart failure medication during
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute strokeAcute strokeMedDRA version: 14.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: PTClassification code 10014498Term: Embolic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10057613Term: Thromboembolic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10067816Term: Cardioembolic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10027580Term: Middle cerebral artery strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: PTClassification code 10043647Term: Thrombotic strokeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2004-003870-27-DKniversity of Nottingham, Research Innovation Services5,000
Completed
Not Applicable
Efficacy of nitric oxide in strokeAcute strokeCirculatory SystemStroke, not specified as haemorrhage or infarctionISRCTN99414122niversity of Nottingham (UK)3,500
Active, not recruiting
Phase 1
A prospective, international, multi-centre, open-label, phase II study investigating the utility of [68Ga]Ga-PentixaFor PET imaging in response assessment (evaluation of the tumour response to the applied therapy) of primary (primary tumour in brain) and isolated secondary (secondary tumour in brain after relapse of a primary tumour not located in the brain) CNS lymphoma patientsCentral nervous system (CNS) lymphomaMedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]EUCTR2021-001711-85-NLPentixaPharm GmbH50
Withdrawn
Phase 2
A prospective, international, multi-centre, open-label,single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma patientsCentral Nervous system lymphomaBrain lymphomaBrain tumor10025322NL-OMON51764PentixaPharm GmbH6
Active, not recruiting
Phase 1
A prospective, international, multi-centre, open-label, phase II study investigating the utility of [68Ga]Ga-PentixaFor PET imaging in response assessment (evaluation of the tumour response to the applied therapy) of primary (primary tumour in brain) and isolated secondary (secondary tumour in brain after relapse of a primary tumour not located in the brain) CNS lymphoma patientsCentral nervous system (CNS) lymphomaMedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]EUCTR2021-001711-85-DKPentixaPharm GmbH50