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Register:	EUCTR
Last refreshed on:	30 June 2019
Main ID:	EUCTR2005-003182-16-GB
Date of registration:	29/07/2005
Prospective Registration:	Yes
Primary sponsor:	Addenbrooke's Hospital Trust
Public title:	Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs.
Scientific title:	Blood Pressure Optimisation In Patients With Polycystic Kidney Disease And Hypertension By Rotation Through The Main Therapeutic Classes Of Antihypertensive Drugs.
Date of first enrolment:	26/08/2005
Target sample size:	42
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003182-16
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other:
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
• 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

Exclusion criteria:
• 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Polycystic kidney disease

Intervention(s)

Trade Name: CARDURA
Product Name: DOXAZOSIN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: MONOCOR
Product Name: BISOPROLOL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: ZESTRIL
Product Name: LISINOPRIL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: ISTIN
Product Name: AMLODIPINE
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: AMIAS
Product Name: CANDESARTAN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: APRINOX
Product Name: BENDROFLUMETHIAZIDE
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective:

Main Objective: To identify best antihypertensive agent to control blood pressure

Primary end point(s): FALL IN SYSTOLIC AND DIASTOLIC BLOOD PRESSURE

Secondary Outcome(s)

Secondary ID(s)

A07329

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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