Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Parkinson's Disease Clinical Trial

Official title:

Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061567
• Other study ID #: 248.675
• Status: Completed
• Phase: N/A
• First received: December 24, 2009
• Last updated: June 6, 2014
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medicines and Medical Devices AgencyEstonia: The State Agency of MedicineKazakhstan: Ethical CommissionRomania: Ministry of Public HealthSerbia: Ethics CommitteeSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Observational

Clinical Trial Summary

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1814
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Early and advanced idiopathic Parkinson's disease

• Male and female patients over 18 years of age

• Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Exclusion criteria:

• Ongoing treatment with pramipexole ER

• Exclusion criteria in line with the pramipexole ER SmPC:

In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Austria	Boehringer Ingelheim Investigational Site 1	Bad Ischl
Austria	Boehringer Ingelheim Investigational Site 2	Bad Radkersburg
Austria	Boehringer Ingelheim Investigational Site 3	Baden
Austria	Boehringer Ingelheim Investigational Site 4	Baden
Austria	Boehringer Ingelheim Investigational Site 5	Bludenz
Austria	Boehringer Ingelheim Investigational Site 6	Braunau/Inn
Austria	Boehringer Ingelheim Investigational Site 7	Deutschlandsberg
Austria	Boehringer Ingelheim Investigational Site 8	Dornbirn
Austria	Boehringer Ingelheim Investigational Site 9	Dornbirn
Austria	Boehringer Ingelheim Investigational Site 10	Ehenbichl
Austria	Boehringer Ingelheim Investigational Site 11	Eisenstadt
Austria	Boehringer Ingelheim Investigational Site 12	Eisenstadt
Austria	Boehringer Ingelheim Investigational Site 13	Feldbach
Austria	Boehringer Ingelheim Investigational Site 14	Feldkirchen
Austria	Boehringer Ingelheim Investigational Site 15	Gänserndorf
Austria	Boehringer Ingelheim Investigational Site 16	Graz
Austria	Boehringer Ingelheim Investigational Site 17	Graz
Austria	Boehringer Ingelheim Investigational Site 18	Graz
Austria	Boehringer Ingelheim Investigational Site 19	Graz
Austria	Boehringer Ingelheim Investigational Site 20	Grieskirchen
Austria	Boehringer Ingelheim Investigational Site 21	Grimmenstein
Austria	Boehringer Ingelheim Investigational Site 22	Hainburg
Austria	Boehringer Ingelheim Investigational Site 23	Hall/Tirol
Austria	Boehringer Ingelheim Investigational Site 24	Hallein
Austria	Boehringer Ingelheim Investigational Site 25	Hartberg
Austria	Boehringer Ingelheim Investigational Site 26	Hermagor
Austria	Boehringer Ingelheim Investigational Site 27	Hohenems
Austria	Boehringer Ingelheim Investigational Site 28	Horn
Austria	Boehringer Ingelheim Investigational Site 29	Horn
Austria	Boehringer Ingelheim Investigational Site 30	Imst
Austria	Boehringer Ingelheim Investigational Site 31	Innsbruck
Austria	Boehringer Ingelheim Investigational Site 32	Innsbruck
Austria	Boehringer Ingelheim Investigational Site 33	Innsbruck
Austria	Boehringer Ingelheim Investigational Site 34	Judenburg
Austria	Boehringer Ingelheim Investigational Site 35	Kapfenberg
Austria	Boehringer Ingelheim Investigational Site 36	Klagenfurt
Austria	Boehringer Ingelheim Investigational Site 37	Klagenfurt
Austria	Boehringer Ingelheim Investigational Site 38	Klagenfurt
Austria	Boehringer Ingelheim Investigational Site 39	Klagenfurt
Austria	Boehringer Ingelheim Investigational Site 40	Knittelfeld
Austria	Boehringer Ingelheim Investigational Site 41	Krems
Austria	Boehringer Ingelheim Investigational Site 42	Kufstein
Austria	Boehringer Ingelheim Investigational Site 43	Laßnitzhöhe
Austria	Boehringer Ingelheim Investigational Site 44	Leibnitz
Austria	Boehringer Ingelheim Investigational Site 45	Leoben
Austria	Boehringer Ingelheim Investigational Site 46	Lienz
Austria	Boehringer Ingelheim Investigational Site 47	Lienz
Austria	Boehringer Ingelheim Investigational Site 48	Lilienfeld
Austria	Boehringer Ingelheim Investigational Site 49	Linz
Austria	Boehringer Ingelheim Investigational Site 50	Linz
Austria	Boehringer Ingelheim Investigational Site 51	Melk
Austria	Boehringer Ingelheim Investigational Site 52	Mürzzuschlag
Austria	Boehringer Ingelheim Investigational Site 53	Neulengbach
Austria	Boehringer Ingelheim Investigational Site 54	Neulengbach
Austria	Boehringer Ingelheim Investigational Site 55	Neunkirchen
Austria	Boehringer Ingelheim Investigational Site 56	Neunkirchen
Austria	Boehringer Ingelheim Investigational Site 57	Neusiedl am See
Austria	Boehringer Ingelheim Investigational Site 58	Oberwart
Austria	Boehringer Ingelheim Investigational Site 59	Oberwart
Austria	Boehringer Ingelheim Investigational Site 60	Oberwart
Austria	Boehringer Ingelheim Investigational Site 61	Regelsbrunn
Austria	Boehringer Ingelheim Investigational Site 62	Ried im Innkreis
Austria	Boehringer Ingelheim Investigational Site 63	Ried im Innkreis
Austria	Boehringer Ingelheim Investigational Site 64	Rohrbach
Austria	Boehringer Ingelheim Investigational Site 65	Salzburg
Austria	Boehringer Ingelheim Investigational Site 66	Salzburg
Austria	Boehringer Ingelheim Investigational Site 67	Salzburg
Austria	Boehringer Ingelheim Investigational Site 68	Salzburg
Austria	Boehringer Ingelheim Investigational Site 69	Scheibbs
Austria	Boehringer Ingelheim Investigational Site 70	St. Johann im Pongau
Austria	Boehringer Ingelheim Investigational Site 71	St. Pölten
Austria	Boehringer Ingelheim Investigational Site 72	St. Pölten
Austria	Boehringer Ingelheim Investigational Site 73	St. Veit an der Glan
Austria	Boehringer Ingelheim Investigational Site 74	Telfs
Austria	Boehringer Ingelheim Investigational Site 75	Tulln
Austria	Boehringer Ingelheim Investigational Site 76	Tullnerbach-Lawies
Austria	Boehringer Ingelheim Investigational Site 77	Villach
Austria	Boehringer Ingelheim Investigational Site 78	Villach
Austria	Boehringer Ingelheim Investigational Site 79	Villach-Warmbad
Austria	Boehringer Ingelheim Investigational Site 80	Vöcklabruck
Austria	Boehringer Ingelheim Investigational Site 81	Vöcklabruck
Austria	Boehringer Ingelheim Investigational Site 82	Völkermarkt
Austria	Boehringer Ingelheim Investigational Site 83	Wagna
Austria	Boehringer Ingelheim Investigational Site 100	Wien
Austria	Boehringer Ingelheim Investigational Site 101	Wien
Austria	Boehringer Ingelheim Investigational Site 102	Wien
Austria	Boehringer Ingelheim Investigational Site 103	Wien
Austria	Boehringer Ingelheim Investigational Site 104	Wien
Austria	Boehringer Ingelheim Investigational Site 105	Wien
Austria	Boehringer Ingelheim Investigational Site 106	Wien
Austria	Boehringer Ingelheim Investigational Site 107	Wien
Austria	Boehringer Ingelheim Investigational Site 84	Wien
Austria	Boehringer Ingelheim Investigational Site 85	Wien
Austria	Boehringer Ingelheim Investigational Site 86	Wien
Austria	Boehringer Ingelheim Investigational Site 87	Wien
Austria	Boehringer Ingelheim Investigational Site 88	Wien
Austria	Boehringer Ingelheim Investigational Site 89	Wien
Austria	Boehringer Ingelheim Investigational Site 90	Wien
Austria	Boehringer Ingelheim Investigational Site 91	Wien
Austria	Boehringer Ingelheim Investigational Site 92	Wien
Austria	Boehringer Ingelheim Investigational Site 93	Wien
Austria	Boehringer Ingelheim Investigational Site 94	Wien
Austria	Boehringer Ingelheim Investigational Site 95	Wien
Austria	Boehringer Ingelheim Investigational Site 96	Wien
Austria	Boehringer Ingelheim Investigational Site 97	Wien
Austria	Boehringer Ingelheim Investigational Site 98	Wien
Austria	Boehringer Ingelheim Investigational Site 99	Wien
Austria	Boehringer Ingelheim Investigational Site 108	Wiener Neustadt
Austria	Boehringer Ingelheim Investigational Site 109	Wolfsberg
Austria	Boehringer Ingelheim Investigational Site 110	Zirl
Austria	Boehringer Ingelheim Investigational Site 111	Zwettl
Estonia	Boehringer Ingelheim Investigational Site 115	Järvamaa
Estonia	Boehringer Ingelheim Investigational Site 114	Kohtla-Järve
Estonia	Boehringer Ingelheim Investigational Site 121	Kuressaare
Estonia	Boehringer Ingelheim Investigational Site 116	Rakvere
Estonia	Boehringer Ingelheim Investigational Site 112	Tallinn
Estonia	Boehringer Ingelheim Investigational Site 113	Tallinn
Estonia	Boehringer Ingelheim Investigational Site 117	Tartu
Estonia	Boehringer Ingelheim Investigational Site 118	Valga
Estonia	Boehringer Ingelheim Investigational Site 119	Viimsi
Estonia	Boehringer Ingelheim Investigational Site 120	Viljandi
Kazakhstan	Boehringer Ingelheim Investigational Site 283	Almaty
Kazakhstan	Boehringer Ingelheim Investigational Site 284	Astana
Kazakhstan	Boehringer Ingelheim Investigational Site 282	Shymkent
Romania	Boehringer Ingelheim Investigational Site 193	Alba Iulia
Romania	Boehringer Ingelheim Investigational Site 194	Bacau
Romania	Boehringer Ingelheim Investigational Site 195	Bacau
Romania	Boehringer Ingelheim Investigational Site 196	Bacau
Romania	Boehringer Ingelheim Investigational Site 197	Baia Mare
Romania	Boehringer Ingelheim Investigational Site 198	Baia Mare
Romania	Boehringer Ingelheim Investigational Site 199	Botosani
Romania	Boehringer Ingelheim Investigational Site 200	Brasov
Romania	Boehringer Ingelheim Investigational Site 201	Brasov
Romania	Boehringer Ingelheim Investigational Site 202	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 203	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 204	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 205	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 206	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 207	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 208	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 209	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 210	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 211	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 212	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 213	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 214	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 215	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 216	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 217	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 218	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 219	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 220	Buzau
Romania	Boehringer Ingelheim Investigational Site 221	Buzau
Romania	Boehringer Ingelheim Investigational Site 222	Campulung
Romania	Boehringer Ingelheim Investigational Site 223	Cluj-Napoca
Romania	Boehringer Ingelheim Investigational Site 224	Cluj-Napoca
Romania	Boehringer Ingelheim Investigational Site 225	Constanta
Romania	Boehringer Ingelheim Investigational Site 226	Constanta
Romania	Boehringer Ingelheim Investigational Site 227	Constanta
Romania	Boehringer Ingelheim Investigational Site 228	Craiova
Romania	Boehringer Ingelheim Investigational Site 229	Craiova
Romania	Boehringer Ingelheim Investigational Site 230	Craiova
Romania	Boehringer Ingelheim Investigational Site 231	Craiova
Romania	Boehringer Ingelheim Investigational Site 232	Craiova
Romania	Boehringer Ingelheim Investigational Site 233	Curtea de Arges
Romania	Boehringer Ingelheim Investigational Site 234	Focsani
Romania	Boehringer Ingelheim Investigational Site 235	Focsani
Romania	Boehringer Ingelheim Investigational Site 236	Galati
Romania	Boehringer Ingelheim Investigational Site 237	Iasi
Romania	Boehringer Ingelheim Investigational Site 238	Iasi
Romania	Boehringer Ingelheim Investigational Site 239	Iasi
Romania	Boehringer Ingelheim Investigational Site 240	Medgidia
Romania	Boehringer Ingelheim Investigational Site 241	Oradea
Romania	Boehringer Ingelheim Investigational Site 242	Oradea
Romania	Boehringer Ingelheim Investigational Site 243	Piatra Neamt
Romania	Boehringer Ingelheim Investigational Site 244	Piatra Neamt
Romania	Boehringer Ingelheim Investigational Site 245	Pitesti
Romania	Boehringer Ingelheim Investigational Site 246	Pitesti
Romania	Boehringer Ingelheim Investigational Site 247	Ploiesti
Romania	Boehringer Ingelheim Investigational Site 248	Prahova
Romania	Boehringer Ingelheim Investigational Site 249	Radauti
Romania	Boehringer Ingelheim Investigational Site 250	Ramnicu Valcea
Romania	Boehringer Ingelheim Investigational Site 251	Ramnicu Valcea
Romania	Boehringer Ingelheim Investigational Site 252	Ramnicu Valcea
Romania	Boehringer Ingelheim Investigational Site 253	Satu Mare
Romania	Boehringer Ingelheim Investigational Site 254	Satu Mare
Romania	Boehringer Ingelheim Investigational Site 255	Sibiu
Romania	Boehringer Ingelheim Investigational Site 256	Sibiu
Romania	Boehringer Ingelheim Investigational Site 257	Simleul Silvaniei
Romania	Boehringer Ingelheim Investigational Site 258	Slobozia
Romania	Boehringer Ingelheim Investigational Site 259	Suceava
Romania	Boehringer Ingelheim Investigational Site 260	Targoviste
Romania	Boehringer Ingelheim Investigational Site 261	Targoviste
Romania	Boehringer Ingelheim Investigational Site 262	Targu Mures
Romania	Boehringer Ingelheim Investigational Site 263	Tarnaveni
Romania	Boehringer Ingelheim Investigational Site 264	Tarnaveni
Romania	Boehringer Ingelheim Investigational Site 265	Timisoara
Romania	Boehringer Ingelheim Investigational Site 266	Timisoara
Romania	Boehringer Ingelheim Investigational Site 267	Timisoara
Romania	Boehringer Ingelheim Investigational Site 268	Timisoara
Romania	Boehringer Ingelheim Investigational Site 269	Tulcea
Romania	Boehringer Ingelheim Investigational Site 270	Tulcea
Romania	Boehringer Ingelheim Investigational Site 271	Tulcea
Romania	Boehringer Ingelheim Investigational Site 272	Turda
Romania	Boehringer Ingelheim Investigational Site 273	Turnu Magurele
Romania	Boehringer Ingelheim Investigational Site 274	Zalau
Serbia	Boehringer Ingelheim Investigational Site 275	Belgrade
Serbia	Boehringer Ingelheim Investigational Site 276	Belgrade
Serbia	Boehringer Ingelheim Investigational Site 278	Kragujevac
Serbia	Boehringer Ingelheim Investigational Site 281	Kraljevo
Serbia	Boehringer Ingelheim Investigational Site 279	Nis
Serbia	Boehringer Ingelheim Investigational Site 277	Novi Sad
Serbia	Boehringer Ingelheim Investigational Site 280	Uzice
Slovakia	Boehringer Ingelheim Investigational Site 122	Banská Bystrica
Slovakia	Boehringer Ingelheim Investigational Site 123	Bardejov
Slovakia	Boehringer Ingelheim Investigational Site 124	Bardejov
Slovakia	Boehringer Ingelheim Investigational Site 125	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 126	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 127	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 128	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 129	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 130	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 131	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 132	Bratislava
Slovakia	Boehringer Ingelheim Investigational Site 133	Brezno
Slovakia	Boehringer Ingelheim Investigational Site 134	Detva
Slovakia	Boehringer Ingelheim Investigational Site 135	Dolný Kubín
Slovakia	Boehringer Ingelheim Investigational Site 136	Dolný Kubín
Slovakia	Boehringer Ingelheim Investigational Site 137	Hlohovec
Slovakia	Boehringer Ingelheim Investigational Site 138	Hlohovec
Slovakia	Boehringer Ingelheim Investigational Site 139	Humenné
Slovakia	Boehringer Ingelheim Investigational Site 140	Kezmarok
Slovakia	Boehringer Ingelheim Investigational Site 141	Kezmarok
Slovakia	Boehringer Ingelheim Investigational Site 142	Komárno
Slovakia	Boehringer Ingelheim Investigational Site 143	Kosice
Slovakia	Boehringer Ingelheim Investigational Site 144	Kosice
Slovakia	Boehringer Ingelheim Investigational Site 145	Kosice
Slovakia	Boehringer Ingelheim Investigational Site 146	Kosice
Slovakia	Boehringer Ingelheim Investigational Site 147	Kosice
Slovakia	Boehringer Ingelheim Investigational Site 148	Krompachy
Slovakia	Boehringer Ingelheim Investigational Site 149	Liptovský Mikulás
Slovakia	Boehringer Ingelheim Investigational Site 150	Lucenec
Slovakia	Boehringer Ingelheim Investigational Site 151	Lucenec
Slovakia	Boehringer Ingelheim Investigational Site 152	Lucenec
Slovakia	Boehringer Ingelheim Investigational Site 153	Martin
Slovakia	Boehringer Ingelheim Investigational Site 154	Martin
Slovakia	Boehringer Ingelheim Investigational Site 155	Myjava
Slovakia	Boehringer Ingelheim Investigational Site 156	Námestovo
Slovakia	Boehringer Ingelheim Investigational Site 157	Nitra
Slovakia	Boehringer Ingelheim Investigational Site 158	Nitra
Slovakia	Boehringer Ingelheim Investigational Site 159	Nitra
Slovakia	Boehringer Ingelheim Investigational Site 160	Nitra
Slovakia	Boehringer Ingelheim Investigational Site 161	Pezinok
Slovakia	Boehringer Ingelheim Investigational Site 162	Piestany
Slovakia	Boehringer Ingelheim Investigational Site 163	Presov
Slovakia	Boehringer Ingelheim Investigational Site 164	Presov
Slovakia	Boehringer Ingelheim Investigational Site 165	Presov
Slovakia	Boehringer Ingelheim Investigational Site 166	Presov
Slovakia	Boehringer Ingelheim Investigational Site 167	Sahy
Slovakia	Boehringer Ingelheim Investigational Site 168	Sala
Slovakia	Boehringer Ingelheim Investigational Site 169	Skalica
Slovakia	Boehringer Ingelheim Investigational Site 170	Stará Lubovna
Slovakia	Boehringer Ingelheim Investigational Site 171	Surany
Slovakia	Boehringer Ingelheim Investigational Site 172	Topolcany
Slovakia	Boehringer Ingelheim Investigational Site 173	Trebisov
Slovakia	Boehringer Ingelheim Investigational Site 174	Trencín
Slovakia	Boehringer Ingelheim Investigational Site 175	Trnava
Slovakia	Boehringer Ingelheim Investigational Site 176	Trnava
Slovakia	Boehringer Ingelheim Investigational Site 177	Trstená
Slovakia	Boehringer Ingelheim Investigational Site 178	Vranov nad Top?ou
Slovakia	Boehringer Ingelheim Investigational Site 179	Ziar nad Hronom
Slovakia	Boehringer Ingelheim Investigational Site 180	Zilina
Slovakia	Boehringer Ingelheim Investigational Site 182	Zlaté Moravce
Slovakia	Boehringer Ingelheim Investigational Site 181	Zvolen
Slovenia	Boehringer Ingelheim Investigational Site 183	Celje
Slovenia	Boehringer Ingelheim Investigational Site 184	Lesce
Slovenia	Boehringer Ingelheim Investigational Site 185	Ljubljana
Slovenia	Boehringer Ingelheim Investigational Site 186	Ljubljana
Slovenia	Boehringer Ingelheim Investigational Site 187	Maribor
Slovenia	Boehringer Ingelheim Investigational Site 188	Maribor
Slovenia	Boehringer Ingelheim Investigational Site 190	Sempeter
Slovenia	Boehringer Ingelheim Investigational Site 191	Sempeter
Slovenia	Boehringer Ingelheim Investigational Site 189	Slovenj Gradec
Slovenia	Boehringer Ingelheim Investigational Site 192	Velenje

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Estonia,  Kazakhstan,  Romania,  Serbia,  Slovakia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	The number of patients with any adverse events (AEs), patients with drug-related AEs.	From the treatment initiation to the end of study, on average 92.9 days	No
Primary	Proportion of Patients With Withdrawals Due to Adverse Events.	Patients who discontinued treatment due to adverse events including deaths.	16 weeks	No
Secondary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score	Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.	Baseline and the end of study (up to 16 weeks)	No
Secondary	Clinical Global Impression of Improvement (CGI-I) Responder Rate	The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.	Baseline and the end of study (up to 16 weeks)	No
Secondary	Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction	The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.	Baseline and the end of study (up to 16 weeks)	No
Secondary	Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score	The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement	Baseline and the end of study (up to 16 weeks)	No