Hypertension
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Tablet
CAS Number: 173334571
Other descriptive name: ALISKIREN
Trade Name: Coversyl 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PERIND
Sponsors
Prof Alice Stanton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: • 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) o Men = (140 - age) X weight (kg) / (0.814 X creatinine level (micromol/l) o Women = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Hence the specific primary objectives of this trial are; 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. 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. ;Secondary Objective: Secondary: To store DNA and clinical data so as to allow further appropriate pharmacogenetic analyses. ;Primary end point(s): Primary endpoint is the change from baseline in 24-hour systolic BP with each drug treatment | — |
Countries
Ireland
Outcome results
None listed