Rotation of antihypertensive drugs in ethnic groups
| ISRCTN | ISRCTN08931855 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08931855 |
| Secondary identifying numbers | NTR384 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 03/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R.P. Koopmans
Scientific
Scientific
Academic Medical Centre
Department of Pharmacology and Therapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| r.p.koopmans@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ROTATIE |
| Study objectives | Inter-individual variation in antihypertensive drug response can be predicted through lifestyle, demographics and plasma drug levels. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lisinopril, nebivolol, barnidipine, HCl thiazide, eprosartan |
| Primary outcome measure | 1. Office blood pressure measured with an automatic device 2. Side effects measured with a questionnaire |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2001 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 |
| Key inclusion criteria | Subjects with uncomplicated hypertension between the ages of 36 and 60 years. |
| Key exclusion criteria | 1. Serious hypertensive organ damage 2. Co-morbidity |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Yamanouchi Europe BV (The Netherlands)
No information available
Solvay SA (Belgium)
No information available
Menarini Benelux NV (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
