DDrare: Database of Drug Development for Rare Diseases

195. ヌーナン症候群
［臨床試験数：14，薬物数：15（DrugBank：5），標的遺伝子数：2，標的パスウェイ数：9］

Searched query = "Noonan syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = Glucose; Growth hormone; LOVASTATIN; Lamotrigin; Lamotrigin beta; Lovastatin; MAXOMAT ®, biosynthetic growth hormone; MEK162; Norditropin 24 IU; Norditropin SimpleXx; Other: Oral Glucose tolerance test; RhIGF-1/rhIGFBP-3; RhIGFBP-3; Simvastatin; Somatropin

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01556568 (ClinicalTrials.gov)	February 2012	15/3/2012	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy	An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy	Cardiomegaly	Drug: MEK162	Array Biopharma, now a wholly owned subsidiary of Pfizer	NULL	Withdrawn	18 Years	65 Years	All	0	Phase 2	United States;United Kingdom
2	EUCTR2011-003392-10-GB (EUCTR)	23/01/2012	24/08/2011	A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.	An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy.	Noonan syndrome hypertrophic cardiomyopathy MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: MEK162	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	22		United Kingdom;United States

No.

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enrollment

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registration

Public_title

Scientific_title

Condition

Intervention

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sponsor

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sponsor

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Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

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size

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NCT01556568
(ClinicalTrials.gov)

February 2012

15/3/2012

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy

An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy

Cardiomegaly

Drug: MEK162

Array Biopharma, now a wholly owned subsidiary of Pfizer

NULL

Withdrawn

18 Years

65 Years

All

Phase 2

United States;United Kingdom

EUCTR2011-003392-10-GB
(EUCTR)

23/01/2012

24/08/2011

A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.

An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy.

Noonan syndrome hypertrophic cardiomyopathy
MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Code: MEK162

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;United States