Cardiac heart Heart
Conditions
Interventions
The pharma partner's candidate drug will be compared to placebo. The placebo
will look like the pharma partner's candidate drug but it will not contain
active ingredients. A placebo has no medical e
Sponsors
Roche Diagnostics International AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For diagnostic trial, samples to arrive frozen for testing. Samples must be serum samples.
Exclusion criteria
Exclusion criteria: For diagnostic trial, inclusion criteria not fulfilled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to support the pharma partner*s Phase III trial using Tina-quant Lipoprotein (a) RxDx assay for subject selection and optional batch testing of follow-up samples. This study is carried out to evaluate the performance of Tina-quant Lipoprotein (a) RxDx assay in circumstances similar to the routine conditions of use. The data obtained from this study will be used in the performance evaluation process and be part of the clinical evidence for the device. Data generated under this study in combination with the clinical outcomes of Phase III trial, if it reaches the safety and efficacy endpoint, will be used to validate the assay clinically and thus for registration of the product with regulatory authorities. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Taiwan, United States
Contacts
Public ContactI Huskic
Amgen
Outcome results
None listed