Value through Innovation27 July 2016

Clinical Study Results

  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.524
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson’s disease (PD)

    Study Document Trial synopsis 248.524_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.525
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIIa
    Study Title

    A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD)

    Study Document Trial synopsis 248.525_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.538
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A two year open label, randomized, parallel group, blinded assessment ophthalmologic safety study of pramipexole IR versus ropinirole in early Parkinson’s Disease patients

    Study Document Trial synopsis 248.538_DS_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.633
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term safety study of open-label pramipexole extended release (ER) in patients with early Parkinson’s disease (PD)

    Study Document Trial synopsis 248.633_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.634
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson

    Study Document Trial synopsis 248.634_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.544
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Open label, exploratory clinical trial to assess the safety, tolerability and effectiveness of a switching from talipexole to pramipexole

    Study Document Trial synopsis 248.544_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.547
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special survey on patients with Parkinson's disease on long-term treatment

    Study Document Trial synopsis 248.547_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.549
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special drug use result survey in 3 years treatment in patients with Parkinson

    Study Document Trial synopsis 248.549_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.559
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical Study On Pramipexole’s Efficacy and Safety in Patients with Parkinson’s Disease (COPE w/ PD)

    Study Document Trial synopsis 248.559_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.595
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease

    Study Document Trial synopsis 248.595_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.596
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo, administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms

    Study Document Trial synopsis 248.596 english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.598
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observational Study Concerning the Titration Schedule of SIFROL ® (Pramipexole).

    Study Document Trial synopsis 248.598_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.599
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Mirapex PMS study final report

    Study Document Trial synopsis 248.599_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.610
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIb/III
    Study Title

    A double-blind, double-dummy, randomised, parallel-group study to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER versus pramipexole IR administered orally for 12 weeks in patients with Parkinson’s disease (PD) on L-dopa therapy, followed by a 52-week open-label long-term treatment period to evaluate the long-term safety and efficacy of pramipexole ER

    Study Document Trial synopsis 248.610_DS_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.613
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) "First Presentation"of MIRAPEXIN in Parkinson Patients

    Study Document Trial synopsis 248.613_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.619
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A cross-sectional, retrospective screening and case-control study examining the frequency of, and risk factors associated with, impulse control disorders in Parkinson’s disease patients treated with MIRAPEX® (pramipexole) and other anti-parkinson agents (DOMINION Study)

    Study Document Trial synopsis 248.619_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.622
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, active (pramipexole 0.5 mg tid) and placebo controlled, efficacy study of pramipexole given 0.5 mg and 0.75 mg bid over a 12-week treatment phase in early Parkinson’s disease patients (PramiBID)

    Study Document Trial synopsis 248.622_DS_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.337
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase II
    Study Title

    Early Phase II study of SND 919 tablets in Parkinson’s disease

    Study Document Trial synopsis 248.337_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.360
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observation of the efficacy and tolerability of Sifrol® in patients with advanced idiopathic Parkinson’s disease

    Study Document Trial synopsis 248.360_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.505
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, placebo-controlled, randomized, multicenter trial to compare the safety and efficacy of oral administration or pramipexole up to 4.5 mg and bromocriptine up to 22.5 mg combined with L-dopa in advanced Parkinson’s disease

    Study Document Trial synopsis 248.505_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.506
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    Long-term administration study of SND 919 tablets in Parkinson

    Study Document Trial synopsis 248.506_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.511
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    The effect of Sifrol® on tremor and depression in patients with idiopathic Parkinson’s disease patients. Observational study

    Study Document Trial synopsis 248.511_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.516
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized single-blind placebo controlled comparative trial of Pramipexole tablets and Bromocriptine tablets in patients with Parkinson’s disease.

    Study Document Trial synopsis 248.516_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.527
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Management of Parkinson´s Disease patients at their first visits in a neurological practice

    Study Document Trial synopsis 248.527_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.539
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance study of Sifrol - Monotherapy in patients with idiopathic Parkinson

    Study Document Trial synopsis 248.539_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.649
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Non-motor symptoms (depressive symptoms) of Parkinson’s disease and their course under pramipexole treatment

    Study Document Trial synopsis 248.649_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.655
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Sifrol onset of action and impact on RLS: a 12-weeks observational study in patients with primary RLS

    Study Document Trial synopsis 248.655_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.657
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Kinetic tremor in Parkinsons disease: its course under Mirapexin® treatment and impact on Quality of Life

    Study Document Trial synopsis 248.657_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.636
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, randomized, parallel groups study to assess the Efficacy, Safety and Tolerability of switching patients with early Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ER or Pramipexole IR.

    Study Document Trial synopsis 248.636_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.635
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance of BI-Sifrol® (Pramipexole). Special drug use result survey in Parkinson’s disease patients with depressive symptoms

    Study Document Trial synopsis 248.635_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.674
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Influence of Pramipexole extended release on medication adherence in real life care of Parkinson’s disease

    Study Document Trial synopsis 248.674_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.671
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, double-dummy, randomised, parallel-group study comparing the efficacy, safety, and tolerability of pramipexole ER versus pramipexole IR administered orally for 18 weeks in Chinese Parkinson's disease (PD) patients who can be concomitantly treated with L-dopa

    Study Document Trial synopsis 248.671_DS_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.682
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Safety of Pramipexole monotherapy or combination therapy in Chinese patients   with Parkinson’s disease: a 12-week post-marketing surveillance

    Study Document Trial synopsis 248.682_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.342
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase I
    Study Title

    Matched pair, assessor blinded, open label clinical trial to assess the ophthalmologic safety of ongoing long term oral treatment with pramipexole compared to bromocriptine or other dopamine agonists in patients with Parkinson's disease.

    Study Document Trial synopsis 248.342_CO english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.648
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study in Parkinson's disease of the primary carepopulation of patients treated with pramipexole by neurologists in France (ETAP)

    Study Document Trial synopsis 248.648 english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.548
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of BI-Sifrol (R) (Pramipexole) Special survey on patients with Parkinson’s disease and renal dysfunction

    Study Document Trial synopsis 248.548 english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.517
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    SIFROL - Switch Post Marketing Surveillance Study in Patients with idiopathic Parkinson's disease

    Study Document Trial synopsis 248.517 english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.680
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Special Survey on Long-term Drug Use of Mirapex®-LA Tablets (Pramipexole extended-release) in Patients with Parkinson’s Disease

    Study Document Trial synopsis 248.680_DR english
  • SIFROL ® , MIRAPEX ® - Parkinson Disease
    Clinical Study Number 248.675
    Study Indication Parkinson Disease
    Product SIFROL ® ; MIRAPEX ®
    Generic Name Pramipexole
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of the safety and efficacy of pramipexole extended release in patients with Parkinson’s Disease in routine clinical practice

    Study Document Trial synopsis 248.675_DR english

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