ID

21109

Beschrijving

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs; ODM derived from: https://clinicaltrials.gov/show/NCT00549302

Link

https://clinicaltrials.gov/show/NCT00549302

Trefwoorden

Versies (1)
  1. 10-04-17 10-04-17 -
Geüploaded op

10 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT00549302

Engels

Eligibility Hypertension, Pulmonary NCT00549302

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have participated and discontinued in the previous pah placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
Beschrijving

Participation Pulmonary arterial hypertension Placebo controlled study | Pulmonary arterial hypertension Placebo controlled study Discontinued | Worsening Clinical Due to Placebo | Worsening Clinical Due to Tadalafil Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C2973725
UMLS CUI [1,3]
C0599724
UMLS CUI [2,1]
C2973725
UMLS CUI [2,2]
C0599724
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C0332271
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1696465
UMLS CUI [4,1]
C0332271
UMLS CUI [4,2]
C0205210
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C1176316
UMLS CUI [4,5]
C0178602
must have completed week 16 of the previous pah study and had either no clinical worsening or became clinically worse at the week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
Beschrijving

Pulmonary arterial hypertension Clinical Trial Complete | Worsening Clinical Absent | Worsening Clinical Due to Placebo | Worsening Clinical Due to Tadalafil Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0332271
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1696465
UMLS CUI [4,1]
C0332271
UMLS CUI [4,2]
C0205210
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C1176316
UMLS CUI [4,5]
C0178602
females who have a negative urine pregnancy test and are willing to use 2 types of birth control
Beschrijving

Gender Urine pregnancy test negative | Gender Contraceptive methods Type Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332307
UMLS CUI [2,4]
C1265611
be 12 years or older (country specific regulations apply) with parental approval
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
Beschrijving

Participation Placebo controlled study | Worsening Clinical Due to Tadalafil Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0599724
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C1176316
UMLS CUI [2,5]
C0178602
have left-sided heart disease
Beschrijving

Heart Disease Left sided

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443246
have a musculoskeletal disorder that limits being able to get around
Beschrijving

Musculoskeletal Disease Limiting Able to Get Around

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3831759
nitrate use
Beschrijving

Nitrates

Datatype

boolean

Alias
UMLS CUI [1]
C0028125
certain current systemic treatments
Beschrijving

systemic therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1515119
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Similar models

Eligibility Hypertension, Pulmonary NCT00549302

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Participation Pulmonary arterial hypertension Placebo controlled study | Pulmonary arterial hypertension Placebo controlled study Discontinued | Worsening Clinical Due to Placebo | Worsening Clinical Due to Tadalafil Dosage
Item
must have participated and discontinued in the previous pah placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
boolean
C0679823 (UMLS CUI [1,1])
C2973725 (UMLS CUI [1,2])
C0599724 (UMLS CUI [1,3])
C2973725 (UMLS CUI [2,1])
C0599724 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0332271 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1696465 (UMLS CUI [3,4])
C0332271 (UMLS CUI [4,1])
C0205210 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1176316 (UMLS CUI [4,4])
C0178602 (UMLS CUI [4,5])
Pulmonary arterial hypertension Clinical Trial Complete | Worsening Clinical Absent | Worsening Clinical Due to Placebo | Worsening Clinical Due to Tadalafil Dosage
Item
must have completed week 16 of the previous pah study and had either no clinical worsening or became clinically worse at the week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
boolean
C2973725 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0332271 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0332271 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1696465 (UMLS CUI [3,4])
C0332271 (UMLS CUI [4,1])
C0205210 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1176316 (UMLS CUI [4,4])
C0178602 (UMLS CUI [4,5])
Gender Urine pregnancy test negative | Gender Contraceptive methods Type Quantity
Item
females who have a negative urine pregnancy test and are willing to use 2 types of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332307 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Age
Item
be 12 years or older (country specific regulations apply) with parental approval
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Participation Placebo controlled study | Worsening Clinical Due to Tadalafil Dosage
Item
participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
boolean
C0679823 (UMLS CUI [1,1])
C0599724 (UMLS CUI [1,2])
C0332271 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C1176316 (UMLS CUI [2,4])
C0178602 (UMLS CUI [2,5])
Heart Disease Left sided
Item
have left-sided heart disease
boolean
C0018799 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Musculoskeletal Disease Limiting Able to Get Around
Item
have a musculoskeletal disorder that limits being able to get around
boolean
C0026857 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3831759 (UMLS CUI [1,3])
Nitrates
Item
nitrate use
boolean
C0028125 (UMLS CUI [1])
systemic therapy
Item
certain current systemic treatments
boolean
C1515119 (UMLS CUI [1])
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