None listed
Conditions
Interventions
Group 1 Type of group
aliskiren 150 mg orally for 52 weeks
Group name:Group 2 Type of group
ramipril 5 mg orally for 52 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Outpatients, men and women, with an age of 50 years or more. • Patients diagnosed with essential hypertension defined as: a) Patients currently treated with antihypertensive medications at Visit 1. b) Patients with a recent diagnosis who do not have treatment should have a msDBP> 95 mmHg and / or a msSBP> 150 mmHg ( msDBP> 85 mmHg and / or msSBP> 140 mmHg in diabetic patients) at Visit 1. c) Patients with recent diagnosis who do not have treatment should have a msDBP> 90 mmHg and / or a msSBP> 140 mmHg (msDBP S80 mmHg and / or msSBP> 130 mmHg in diabetic patients) at the randomization visit (Visit 2). • Successful high-quality colonoscopy at the baseline including visualization of the entire colon and cecum confirmed by a photograph and biopsy sampling of the rectal and cecal mucosa. • At the time of the procedure, all rectal, colonic or cecal polyps that are in the basal colonoscopy should be completely resected endoscopically. • Patients who are fit and able to participate in the study and who give their consent to do so after the purpose and nature of the Investigation has been clearly explained to them (written informed consent).
Exclusion criteria
Exclusion criteria: • Patients previously treated in an aliskiren study in this development program and who have qualified for randomization or recruitment during the period of active pharmacological treatment. • Current evidence of inflammatory bowel disease, presence of ulcers in the colon (or other indicators of colitis of any type, e.j. erythema or erosions) or colo-rectal carcinoma including carcinoma in situ described in basal colonoscopy. • History of gastrointestinal carcinoma, Crohn´s disease, ulcerative colitis, microscopic colitis (including lymphocytic colitis and collagenous colitis). • History of familial polyposis or hereditary nonpolyposis colo-rectal cancer. • History of diverticulitis confirmed in the 12 months prior to Visit 1. • History of celiac disease (gluten intolerance) • History of melanosis coli or current evidence of this disease in the basal colonoscopy. • History of immunodeficiency disorders (e.j. hypogammaglobulinemia, agammaglobulinemia, HIV, etc). • Chronic use (defined as administration> 1 day a week) of drugs with specific effects on intestinal function and motility (e.j., laxatives, enemas, antispasmodics, antidiarrheals, stool softeners, etc). The use of bolus trainers (fiber, psyllium, etc.) is allowed> 1 day a week except for the week prior to the basal colonoscopy and at the end of the study. The use of H2 receptor antagonists or proton pump inhibitors will be allowed. • Chronic use (defined as administration> 3 days a week) of non-steroidal anti-inflammatory drugs or COX-2 inhibitors. Cardiovascular prophylaxis will be allowed with low doses of aspirin (a165 mg / day) except the week prior to the basal colonoscopy and at the end of the study. • Recent treatment (in the 12 months prior to Visit 1) or ongoing with Immunosuppressants (eg, ciclosporin). • Long-term use (defined as S4 weeks) of oral corticosteroids before Visit 1. • Use of ramipril or aliskiren in the 4 weeks prior to basal colonoscopy. • Chronic use of warfarin. • Severe hypertension (msDBP> 110 mmhg and / or msSBP S180 mmHg taken in the office) • History or evidence of a secondary form of hypertension • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) in the 12 months prior to entering the study. • Serum sodium 5.3 mEq / L (mmol / L) at Visit 1. • Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:defined as hyperplasic polyps, inflammatory polyps, adenomatous polyps or carcinoma before the planned visit of the first year or at that time. It will be assumed that the primary analysis variable has a binary distribution. Measure:presence of an abnormal finding of the colonoscopy Timepoints:before the planned visit of the first year or at that time | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:defined as the proportion of patients with an objective blood pressure of msSBP / msDBP <140/90 mmHg (<130/80 mmHg in diabetic patients), at the end point of Week 8, Week 30 and the end of the study. Measure:comparison of control rates in the two treatment groups Timepoints:at the end point of Week 8, Week 30 and the end of the study. ; Outcome name:In the biopsy samples of rectal and cecum mucosa taken at the baseline and at the end of the study, the presence of hyperplasia and mucosal dysplasia and the severity of the inflammation will be examined. A score will be defined for mucosal hyperplasia, for dysplasia and for the severity of inflammation, respectively. Measure:Presence of hyperplasia and mucosal dysplasia of the colon, severity of inflammation and number of lesions. Timepoints:After treatment | — |
Countries
Argentina, Colombia, France, Germany, India, Peru, Spain, United States
Contacts
Public ContactCarmen Maria La Rosa
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed