A rotation study through the main therapeutic classes of antihypertensive in patients with polycystic kidney disease and hypertension
| ISRCTN | ISRCTN57653760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57653760 |
| Protocol serial number | N0544099293 |
| Sponsor | Department of Health (UK) |
| Funders | Cambridge Consortium - Addenbrookes Hospital (UK), British Heart Foundation (UK), NHS R&D Support Funding (UK) (ref: 2007/08) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/05/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Kevin M O'Shaugnessy
Scientific
Scientific
Box No 110
Clinical Pharmacology Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 245151 ext.2894 |
|---|---|
| kmo22@medschl.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This will be a study in patients with Polycystic Kidney Disease (PKD) and hypertension designed to evaluate: 1. Individual responsiveness to 5 main drug groups: 1.1. Angiotensin Converting Enzyme (ACE)-inhibitor 1.2. Alpha-blockade 1.3. Beta-blockade 1.4. Diuretic 1.5. Calcium antagonist, and 2. Whether lowering blood pressure improves quality of life, Left Ventricular (LV) mass and endothelial function in PKD patients with mild/moderate hypertension and normal renal function. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Hypertension |
| Intervention | Following a 2-week placebo run-in period, patients eligible to enter this crossover, double-blind study will receive in a randomised order, daily, and for a six week period: 1. Amlodipine (5 mg) 2. Doxazosin (1 mg increasing to 4 mg) 3. Lisinopril (2.5 mg increasing to 10 mg) 4. Benrofluazide (2.5 mg) 5. Bisoprolol (5 mg) 6. Placebo Patients will then receive an additional six weeks treatment with the agent that produced the greatest lowering of mean supine blood pressure. Updated 16/05/2014: the trial was stopped in 2008 due to a lack of funding. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amlodipine, doxazosin, lisinopril, benrofluazide, bisoprolol |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/02/2007 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 40 outpatients aged 18 - 65 years. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 24/02/2000 |
| Date of final enrolment | 24/02/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
