Study identification

EU PAS number

EUPAS35589

Study ID

49911

Official title and acronym

Apothekenbasierte, nicht-interventionelle Unbedenklichkeitsprüfung von Hoggar® Night Tabletten/Schmelztabletten unter Alltagsbedingungen (Projekt Alpha)

DARWIN EU® study

No

Study countries

Germany

Study description

The Alpha project is a prospective, non-interventional post-authorization safety study in pharmacies investigating Hoggar® Night tablets/orodispersible tablets. The study is being conducted to collect data on the tolerability of Hoggar® Night under real-life conditions in a large, unselected group of patients. Of particular interest is the possible risk of an increased fall rate in patients ≥ 65 years of age, which is discussed in connection with the intake of antihistamines of the first generation with sedative effect. No valid data are currently available to confirm or refute this risk. The primary objective of this study is to investigate a possible causal relationship between falls in patients at ≥ 65 years of age and the intake of Hoggar® Night. Secondary objectives are the investigation of a possible causal relationship of falls after the intake of Hoggar® Night for the subgroups < 65 years, 65-84 years and ≥ 85 years, the determination of the fall rate of patients ≥ 65 years as well as for the subgroups < 65 years, 65-84 years and ≥ 85 years, and the identification of causes for falls in patients ≥ 65 years. To answer this question, the design of a prospective, multicentric, non-interventional post-authorisation safety study (according to § 63f German Drug Law) interviewing purchasers of Hoggar® Night in pharmacies has been chosen. The study will be conducted with 2,000 patients in 200 to 400 pharmacies. Data collection is planned for quarter III/2020 to quarter II/2022. Data evaluation by means of descriptive statistics and study completion are planned for quarters II and III/2022.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 58 centres are involved in the study

Contact details

Andreas Iwanowitsch

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

STADA Arzneimittel AG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable