Rotation of antihypertensive drugs in ethnic groups
| ISRCTN | ISRCTN08931855 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08931855 |
| Protocol serial number | NTR384 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funders | Yamanouchi Europe BV (The Netherlands), Solvay SA (Belgium), Menarini Benelux NV (Belgium) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, crossover group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lisinopril, nebivolol, barnidipine, HCl thiazide, eprosartan |
| Primary outcome measure(s) |
1. Office blood pressure measured with an automatic device |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
