Renin Genotype and Response to Renin Angiotensin System Blockade.
- Conditions
- Hypertension
- Registration Number
- EUCTR2008-003568-20-IE
- Lead Sponsor
- Prof Alice Stanton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Male or female outpatients
•Age greater than 18 years.
•Written informed consent provided.
•Patients with essential hypertension who are either antihypertensive treatment naïve, or taking a maximum of two antihypertensive agents – beta-blockers and alpha-blockers already prescribed for indications other than hypertension, at a dose which will not change during the study, may be continued.
•Baseline mean 24-hour systolic pressure > 130 mm Hg, and < 160 mm Hg, either on no treatment or on amlodipine 10 mg daily.
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) yes
F.1.3.1 Number of subjects for this age range
•Age less than 18 years old.
•Pregnancy, women who are breast feeding, or with childbearing potential without using a medically accepted method of contraception.
•Presence of any significant acute or chronic illness. In particular participants must not have a history of an acute cardiovascular morbid event within the last 3 months. They must not have suffered with malignant hypertension or congestive heart failure. They must not have a terminal illness.
•Significant baseline electrolyte, serum creatinine or creatinine clearance abnormalities (potassium > 5.5 mmol/l, or serum creatinine > 150 micromol/l, or creatinine clearance < 30mls/minute as assessed by Cockcroft’s formula)
oMen = (140 - age) X weight (kg) / (0.814 X creatinine level (micromol/l)
oWomen = 0.85 X [(140 - age) X weight (kg) / (0.814 X creatinine level (micromol/l)]
•Known secondary hypertension
•Requirement for any specific antihypertensive drug therapy.
•Contra-indications to any of the study drugs.
•Participation in any other studies involving investigational or marketed products within one month prior to entry into this study or concomitantly with this study.
•Participants that are unlikely to comply well with study treatments or with the scheduled visits.
•Participants with a history of alcohol or drug abuse, psychosis, antagonistic personality, or any emotional or intellectual problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary:To confirm that genotyping of the REN-5312C/T polymorphism identifies individuals who have different BP lowering responses to particular blockers of the renin angiotensin system, and therefore validate REN-5312C/T genotyping as a useful pharmacogenetic assay.<br>Hence the specific primary objectives of this trial are; <br>1.To compare the BP lowering responses to a renin inhibitor, an angiotensin receptor blocker, and an angiotensin converting enzyme inhibitor, amongst REN-5312 CC homozygotes.<br>2.To compare the BP lowering responses to a renin inhibitor, an angiotensin receptor blocker, and an angiotensin converting enzyme inhibitor, amongst REN-5312 T allele carriers. <br><br>;Secondary Objective: Secondary:To store DNA and clinical data so as to allow further appropriate pharmacogenetic analyses.<br>;Primary end point(s): Primary endpoint is the change from baseline in 24-hour systolic BP with each drug treatment
- Secondary Outcome Measures
Name Time Method