EUCTR2016-000165-23-GBActive, not recruitingPhase 1
ComparIsoN oF Optimal Hypertension RegiMens (Part of the Ancestry Informative Markers in Hypertension (AIM HY) Programme – AIM HY-INFORM) - ComparIsoN oF Optimal Hypertension RegiMens (AIM HY-INFORM )
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 sitesStarted: June 24, 2016Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •To be included in the trial the participant must:
- •1)Have given written informed consent to participate
- •2)Be aged 18 to 65 years inclusive
- •3)Self-Define Ethnicity: subjects should SELF IDENTIFY into 1 of the three groups below:
- •White British
- •White Irish
- •Any other white background
- •Black or Black British
- •Black Caribbean
- •Black African
- •Any other black background
- •Asian or Asian British
- •Asian Indian
- •Asian Pakistani
- •Asian Bangladeshi
- •Any other Asian background
- •4)Be hypertensive defined as: -
- •Mono-therapy rotation
- •a. Currently untreated with EITHER an ABPM daytime average blood pressure of =135 mmHg (systolic) or = 85 mmHg (diastolic)
- •Home BP measurements using a validated device based on the average of 10 blood pressure readings of =135 mmHg (systolic) or = 85 mmHg (diastolic)
- •b. Patients who may be taking antihypertensive drugs at sub therapeutic doses or in ineffective combinations, and who are felt likely to be controllable on a study drug and willing and able to be washed out, at the discretion of the CI/PI, can enter the trial if they meet the above criteria.
- •Dual therapy rotation
- •a. Treated hypertensive receiving one to three antihypertensive drugs with a blood pressure (ABPM daytime average blood pressure or Home BP as in a.) between 135 or 200 mmHg (systolic) AND between 85 or 110 mmHg (diastolic).
- •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 1320
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •The presence of any of the following will mean participants are ineligible:
- •Participant does not fit into one of the defined ethnic groups e.g. Mixed
- •Pregnant or breastfeeding women
- •Known or suspected secondary hypertension
- •Significant sensitivity or contraindications to any of the study medications
- •Patients taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses
- •Requirement to take any of the study drugs continuously e.g. ACEi and heart failure
- •Any clinically significant hepatic impairment
- •Any clinically significant kidney impairment
- •Concurrent participation in another clinical trial using systemic vasoactive medications known to interact with the study drugs (participation in another study as part of the AIM HY Mechanistic or social science programme will not be an exclusion criteria)
- •Participants who are deemed unsuitable by the investigator on clinical grounds
Investigators
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