Condition category
Circulatory System
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R.P. Koopmans

ORCID ID

Contact details

Academic Medical Centre
Department of Pharmacology and Therapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
r.p.koopmans@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR384

Study information

Scientific title

Acronym

ROTATIE

Study hypothesis

Inter-individual variation in antihypertensive drug response can be predicted through lifestyle, demographics and plasma drug levels.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, active controlled, crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

Randomised, crossover trial. Six-week periods of antihypertensive drug treatment in monotherapy with three weeks washout. Drugs:
1. Lisinopril
2. Nebivolol
3. Barnidipine
4. HCl thiazide
5. Eprosartan

Intervention type

Drug

Phase

Not Specified

Drug names

Lisinopril, nebivolol, barnidipine, HCl thiazide, eprosartan

Primary outcome measures

1. Office blood pressure measured with an automatic device
2. Side effects measured with a questionnaire

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2001

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with uncomplicated hypertension between the ages of 36 and 60 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102

Participant exclusion criteria

1. Serious hypertensive organ damage
2. Co-morbidity

Recruitment start date

01/01/2001

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Industry

Funder name

Yamanouchi Europe BV (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Solvay SA (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Menarini Benelux NV (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes