Optimal Treatment of Drug Resistant Hypertension - Optimal Treatment of Drug Resistant Hypertension

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 sites346 target enrollmentJanuary 19, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension
Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Enrollment: 346
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

January 19, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

•Patients aged 18\-79 years;
•Patients will all have hypertension that is not controlled to target: clinic systolic BP \= 5 mmHg above target (i.e. \= 140 mmHg for non\-diabetic hypertensives or \= 135 mmHg for diabetics), under one of the following conditions:
•a) Treatment for at least 3 months with lisinopril 20 mg (A) \+ amlodipine 10 mg (C)\+bendroflumethiazide 2\.5 mg (D) or their equivalents‡
•b) Patients who have received the three drugs or equivalents specified in a), and are either intolerant to one category, or tolerate only a lower dose (e.g. amlodipine 5 mg or lisinopril 10 mg)
•c) Patients receiving the three drugs or equivalents specified in a), who are receiving additional drugs for their hypertension, may be included if the investigator 1\) feels it is appropriate to stop these additional drugs at the screening visit and 2\) anticipates that the BP criteria for inclusion will be met when re\-checked at the baseline visit
•Patients may be included if the PI anticipates BP criteria for inclusion will be met at randomisation.
•3\. Patients with a home systolic BP average of \>130 mmHg or within 15mmHg of clinic BP over the 4 days prior to the baseline visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes

•1\. Inability to give informed consent;
•2\. Participation in a clinical study involving an investigational drug or device within 4 weeks of screening;
•3\. Secondary or accelerated hypertension;
•4\. Type 1 diabetes;
•5\. eGFR\<45 mls/min;
•6\. Plasma potassium outside of normal range on two successive measurements during screening;
•7\. Pregnancy, planning to conceive, or women of child\-bearing potential, i.e. not using barrier effective contraception;
•8\. Anticipated change of medical status during the trial (e.g. surgical intervention requiring \>2 weeks convalescence);
•9\. Absolute contra\-indication to study drugs (e.g. asthma) or previous intolerance of trial therapy;
•10\. Sustained atrial fibrillation;