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

Phase 1

• Conditions: Hypertension; MedDRA version: 15.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-007149-30-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 346

Inclusion Criteria

•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
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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;
11. Recent (<6 months) cardiovascular event requiring hospitalisation (e.g. myocardial infarction or stroke);
12. Suspected non-adherence to antihypertensive treatment (see above);
13. Requirement for study drug for reason other than to treat hypertension, (e.g. ß-blockers for angina or diuretics other than those to treat hypertension);
14. Current therapy for cancer;
15. Concurrent chronic illness, or other reasons likely to preclude 40 week participation in the study;
16. Clinic Systolic BP >200 mmHg or diastolic BP >120mmHg, with PI discretion to override if home BP measurements are lower
17. Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit that patients life-span or ability to complete the study (e.g. alcohol or drug abuse, disabling or terminal illness, mental disorders);
18. Treatment with any of the following medications;
a. Oral corticosteroids within 3 months of screening. Treatment with systemic corticosteroids is also prohibited during study participation;
b. Chronic stable use, or unstable use of NSAIDs (other than low dose aspirin) is prohibited. Chronic use is defined as >3 consecutive or non-consecutive days of treatment per week. In addition intermittent use of NSAIDs is strongly discouraged throughout the study and NSAIDs if required, must not be used for more than a total of 2 days. For those requiring analgesics during the study, paracetamol is recommended.
c. The use of short acting nitrates (e.g. sublingual nitroglycerin) is permitted. However, participants should not take
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short acting oral nitrates within 4 hours of screening or an subsequent visit;
d. The use of long acting nitrates (e.g. Isordil) is permitted but the dose must be stable for at least 2 weeks prior to screening and randomisation;
e. The use of sympathomimetic decongestants is permitted , however, not within 1 day prior to any study visit/BP assessment;
f. The use of theophylline is permitted but the dose must be stable for at least 4 weeks prior to screening and throughout the study;
g. The use of phosphodiesterase type V inhibitors is permitted; however study participants must refrain from taking these medications for at least 1 day prior to screening or any subsequent study visits;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified