Trial · NCT01270711
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | Year 1 (Year 2006) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | Year 2 (Year 2007) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | Year 3 (Year 2008) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | Year 4 (Year 2009) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | Year 5 (Year 2010) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | Year 6 (Year 2011) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | Year 1 (Year 2006) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | Year 2 (Year 2007) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | Year 3 (Year 2008) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | Year 4 (Year 2009) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | Year 5 (Year 2010) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | Year 6 (Year 2011) | Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | Year 1 (Year 2006) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | Year 2 (Year 2007) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | Year 3 (Year 2008) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | Year 4 (Year 2009) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | Year 5 (Year 2010) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | Year 6 (Year 2011) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Primary | Total Number of Echocardiography Examinations in Cabergoline Users | Baseline (Week 1) up to Week 339 | The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography. |
| Primary | Incidence of Valvular Fibrosis | Baseline (Week 1) up to Week 339 | Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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