Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs.
- Conditions
- Polycystic kidney disease
- Registration Number
- EUCTR2005-003182-16-GB
- Lead Sponsor
- Addenbrooke's Hospital Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
•patients who have given informed consent
•male or female patients aged 18-65 years inclusive
•normal renal function: defined as a creatinine clearance (ml/min/1.73m2) of >=85 in men and >=75 in women
•either treated hypertensives on antihypertensive medication (no more than 2 agents) or untreated patients in whom initiation of treatment will follow the 1999 British Hypertension Society guidelines19 i.e. a seated BP >160/100, OR >140/90 with either end-organ changes or 10-year CHD risk of >15%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
•pregnancy, lactation or child bearing potential and not using reliable contraception or who intend to become pregnant within the next year.
•history of angina, unstable angina, myocardial infarction, heart failure or stroke within the previous six months
•atrial fibrillation or other arrhythmias requiring medication
•accelerated phase hypertension, untreated DBP >120 or secondary hypertension (other than PKD)
•clinically significant abnormal haematological or biochemical findings not attributed to underlying illness or therapy, or any illness such that in the investigator’s opinion the health of the patient would be prejudiced by inclusion in the study
•serious adverse events, contraindications or history of allergy to any of the five treatments in the study
•history of alcoholism, drug abuse or other emotional or intellectual problems likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements.
•donation or receipt of blood within one month before, during or for one month after study completion.
•participation in any other studies involving investigational or marketed products within three months prior to this study or concomitantly with this study.
•A BMI of > 30
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method