Combination drug treatment in moderate-to-severe essential hypertension
| ISRCTN | ISRCTN46173989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46173989 |
| Protocol serial number | N0236066889 |
| Sponsor | Department of Health |
| Funders | St George's Healthcare NHS Trust, The Blood Pressure Unit, NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/10/2016
- 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
Prof Graham A MacGregor
Scientific
Scientific
Blood Pressure Unit
Jenner Wing
St George's Hospital
Blackshaw Road, Tooting
London
SW17 0QT
United Kingdom
| Phone | +44 (0)20 8725 2848 |
|---|---|
| g.macgregor@sghms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Combination drug treatment in moderate-to-severe essential hypertension |
| Study objectives | The aim of this study is to investigate the effect on blood pressure of the addition of moxonidine or doxazosin in 20 patients with moderate-to-severe essential hypertension who are not adequately controlled on triple therapy with amlodipine 5-10 mg once daily (o.d.), enalapril 10 mg b.d. and bendrofluazide 5 mg o.d. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | Only those patients treated for at least one month with amlodipine 5-10mg o.d., enalapril 10-20mg twice daily (b.d.) and bendrofluazide 5mg o.d., will be included in the study if their supine systolic and/or diastolic BP is >160/90 mmHg on two different occasions. A randomised, double-blind, prospective study. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | moxonidine or doxazosin |
| Primary outcome measure(s) |
Control of blood pressure < 150/90 mmHg |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Patients with uncomplicated, moderate-to-severe essential hypertension which is not adequately controlled on triple therapy with amlodipine 5-10 mg once daily (o.d.), enalapril 10-20 mg b.d. and bendrofluazide 5 mg o.d., iv) |
| Key exclusion criteria | Malignant or accelerated hypertension. Serum creatinine >60umol/L, ischaemic heart disease, cerebrovascular disease, impaired liver function, diabetes mellitus, pregnancy or risk of pregnancy, lactation, history of alcoholism, drug abuse or other problems likely to invalidate the informed consent. |
| Date of first enrolment | 01/05/1999 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Blood Pressure Unit
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/10/2016: No publications found in PubMed, verifying study status with principal investigator.
