Essential hypertension
Conditions
Interventions
Trade Name: Rasilez 150 mg Filmtabletten
Product Name: Rasilez 150 mg Filmtabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Aliskiren
CAS Number: 173334-57-1
Concentration unit: mg milligram(
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients, 50 years of age and older. 2. Patients with a diagnosis of essential hypertension defined as either: a. Patients who are currently treated with antihypertensive drug(s) at Visit 1. b. Newly diagnosed patients who are not treated must have a msDBP =95 mmHg and/or a msSBP =150 mmHg (msDBP =85 mmHg and/or msSBP =140 mmHg for diabetic patients) at Visit 1. c. Newly diagnosed patients who are not treated must have a msDBP = 90 mmHg and/or a msSBP =140 mmHg (msDBP =80 mmHg and/or msSBP =130 mmHg for diabetic patients) at the randomization Visit (Visit 2). 3. Successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples 4. All rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure 5. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent). 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
Exclusion criteria
Exclusion criteria: Patients with any of the following at Visit 1 and Visit 2 (unless otherwise stated) will be excluded from participation in the study. 1. Previously treated in an aliskiren study in this development program and who qualified to be randomized or enrolled into the active drug treatment period. 2. Current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type, e.g. erythema or erosions) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy 3. History of gastrointestinal carcinoma, Crohn’s disease, ulcerative colitis, microscopic colitis (including lymphocytic colitis and collagenous colitis). 4. History of confirmed diverticulitis within 12 months of Visit 1. 5. History of familial polyposis or hereditary nonpolyposis colorectal cancer. 6. History of celiac disease (gluten intolerance). 7. History of, or current evidence on the baseline colonoscopy of melanosis coli. 8. History of immunodeficiency disorders (e.g. hypogammaglobulinemia, agammaglobulinemia, HIV, etc). 9. Chronic use (defined as administration >1 day per week) of drugs with specific effects on bowel function and motility (e.g., laxatives, enemas, antispasmodics, antidiarrheals, stool softeners, etc). The use of bulking agents (bran, psyllium, etc) >1 day per week is allowed except in the week prior to both the baseline and end of study colonoscopy procedures. The use of H2-receptor antagonists or proton pump inhibitors will be permitted throughout the trial. 10. Chronic use (defined as administration >3 days per week) of non-steroidal antiinflammatory drugs or COX-2 inhibitors. Low dose aspirin (=165 mg/day) for cardiovascular prophylaxis will be allowed except in the week prior to both the baseline and end of study colonoscopy procedures. 11. Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (eg, Cyclosporin). 12. Long term use (defined as administration =4 weeks) of oral corticosteroids prior to Visit 1. 13. Use of ramipril or aliskiren within 4 weeks prior to the baseline colonoscopy procedure. 14. Chronic use of warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is: To evaluate the occurrence of colonic pathology as defined by the composite endpoint (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas), to ruleout a doubling of the composite endpoint, following one-year of treatment with aliskiren (300 mg) compared to ramipril (10 mg) in patients =50 years of age with essential hypertension.;Secondary Objective: The secondary objectives of the study are: • To assess mucosal hyperplasia, dysplasia, and severity of inflammation in rectal and cecal mucosal biopsy specimens obtained at baseline and following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen • To assess the occurrence of the individual components of the composite endpoint (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. • To assess the number of each component of the composite endpoint (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. ;Primary end point(s): Occurrence of an abnormal colonoscopy finding, defined as hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinoma | — |
Countries
France, Germany, Spain
Outcome results
None listed