Hypertension
Conditions
Keywords
Hypertension, aliskiren, ramipril, colonoscopy
Brief summary
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
Interventions
DRUGAliskiren
Aliskiren 300 mg once a day
DRUGRamipril
Ramipril 10 mg once a day
OTHERPlacebo to Ramipril
Placebo capsules to match ramipril.
OTHERPlacebo to Aliskiren
Placebo tablets to match aliskiren.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension * 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 * All rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure. * 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).
Exclusion criteria
* Previously treated in an aliskiren study. * Current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy. * History of gastrointestinal carcinoma, Crohn's disease, ulcerative colitis, microscopic colitis. * History of familial polyposis or hereditary nonpolyposis colorectal cancer. * History of confirmed diverticulitis within 12 months of Visit 1. * History of celiac disease (gluten intolerance). * History of or current evidence on the baseline colonoscopy of melanosis coli.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Colonic Pathology | 54 weeks | The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. |
| Summary of the End of Study Colonoscopy Results | 54 weeks | During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Each of the Individual Components of Colonic Pathology | 54 weeks | Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. |
| Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | 54 weeks | Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score \> 0 is worsening from baseline in which the maximum possible score is 3. |
| Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | Weeks 8, 30 and End of Study (54 weeks) | The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients) |
Countries
Argentina, Colombia, France, Germany, India, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration. | 375 |
| Ramipril For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study. | 399 |
| Total | 774 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 2 | 1 |
| Overall Study | Abnormal test procedure result(s) | 3 | 2 |
| Overall Study | Administrative problems | 2 | 0 |
| Overall Study | Adverse Event | 34 | 45 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | No longer required study drug | 0 | 1 |
| Overall Study | Protocol deviation | 6 | 5 |
| Overall Study | Subject withdrew consent | 25 | 33 |
| Overall Study | Unsatisfactory therapeutic effect | 8 | 14 |
Baseline characteristics
| Characteristic | Aliskiren | Ramipril | Total |
|---|---|---|---|
| Age Continuous | 59.3 years STANDARD_DEVIATION 6.99 | 59.3 years STANDARD_DEVIATION 6.65 | 59.3 years STANDARD_DEVIATION 6.81 |
| Age, Customized < 65 years | 299 Participants | 313 Participants | 612 Participants |
| Age, Customized 65 years and greater | 76 Participants | 86 Participants | 162 Participants |
| Sex: Female, Male Female | 194 Participants | 194 Participants | 388 Participants |
| Sex: Female, Male Male | 181 Participants | 205 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 163 / 375 | 176 / 399 |
| serious Total, serious adverse events | 28 / 375 | 22 / 399 |
Outcome results
Primary
Percentage of Participants With Colonic Pathology
The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
Time frame: 54 weeks
Population: Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aliskiren | Percentage of Participants With Colonic Pathology | 25.5 Percentage of participants |
| Ramipril | Percentage of Participants With Colonic Pathology | 25.1 Percentage of participants |
Primary
Summary of the End of Study Colonoscopy Results
During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.
Time frame: 54 weeks
Population: Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Suboptimal | 27.4 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with polyps-Cecum/ascending | 11.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with polyps-Descending/sigmoid | 12.1 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Rectum | 7.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of normal mucosal biopsies-Rectum | 3.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-No | 99.4 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-Missing | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-Yes | 1.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Complete colonoscopy performed | 100 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Was cecum reached in procedure | 99.7 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Photos obtained | 99.4 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Took drug affecting bowel function | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Took low dose aspirin during wk prior to procedure | 4.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Optimal | 72.3 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Inadequate | 0.3 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Colonoscopy prep given- PEG containing solution | 96.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Colonoscopy prep given - Other | 3.2 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Occurrence of colon polyps | 29.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with polyps-Transverse | 6.1 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with polyps-Rectum | 8.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Cecum/ascending | 1.3 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Transverse | 1.2 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Descending/sigmoid | 1.5 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Rectum | 1.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Cecum/ascending | 11.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Transverse | 6.1 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Descending/sigmoid | 12.1 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Rectum | 7.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Cecum/ascending | 11.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Transverse | 5.7 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Descending/sigmoid | 10.8 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mucosal abnormalities for colitis | 1.3 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with colitis-Cecum/ascending | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with colitis-Transverse | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with colitis-Descending/sigmoid | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Patients with colitis-Rectum | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Cecum/ascending | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Transverse | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Descending/sigmoid | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Rectum | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Cecum/ascending | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Transverse | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Descending/sigmoid | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Rectum | 0.6 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Normal mucosal biopsies collected-Cecum | 99.4 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Normal mucosal biopsies collected-Rectum | 99.7 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Mean number of normal mucosal biopsies-Cecum | 3.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-Yes | 0.0 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-No | 98.4 Percentage of Participants |
| Aliskiren | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-Missing | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Normal mucosal biopsies collected-Rectum | 99.7 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Descending/sigmoid | 11.7 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with polyps-Transverse | 5.2 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Rectum | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with polyps-Descending/sigmoid | 11.7 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Rectum | 6.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Rectum | 6.2 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-Missing | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Cecum/ascending | 11.1 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-No | 98.8 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Cecum/ascending | 0.9 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-Missing | 0.9 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Transverse | 4.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of normal mucosal biopsies-Cecum | 3.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Complete colonoscopy performed | 100 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Photo taken for polyps-Descending/sigmoid | 10.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Was cecum reached in procedure | 100 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Transverse | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Photos obtained | 99.7 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mucosal abnormalities for colitis | 1.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Took drug affecting bowel function | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of normal mucosal biopsies-Rectum | 3.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Took low dose aspirin during wk prior to procedure | 5.2 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Optimal | 73.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with colitis-Cecum/ascending | 0.9 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Suboptimal | 25.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Descending/sigmoid | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Adequacy of bowel preparation - Inadequate | 0.9 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with colitis-Transverse | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Colonoscopy prep given- PEG containing solution | 97.2 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-No | 98.8 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Colonoscopy prep given - Other | 2.8 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with colitis-Descending/sigmoid | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Occurrence of colon polyps | 26.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with polyps-Cecum/ascending | 11.4 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis photographed-Rectum | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with colitis-Rectum | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Patients with polyps-Rectum | 6.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Malignance for any biopsy samples-Yes | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Cecum/ascending | 1.2 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Cecum/ascending | 0.9 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Transverse | 1.4 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Normal mucosal biopsies collected-Cecum | 99.7 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Descending/sigmoid | 1.5 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Transverse | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Mean number of polyps-Rectum | 1.3 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Inflammation for any biopsy samples-Yes | 0.6 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Cecum/ascending | 11.1 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Area of colitis biopsied-Descending/sigmoid | 0.0 Percentage of Participants |
| Ramipril | Summary of the End of Study Colonoscopy Results | Polyps were completely resected-Transverse | 4.9 Percentage of Participants |
Secondary
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score \> 0 is worsening from baseline in which the maximum possible score is 3.
Time frame: 54 weeks
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 2 | 0 participants |
| Aliskiren | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 3 | 0 participants |
| Aliskiren | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 0 | 295 participants |
| Aliskiren | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score is Missing | 2 participants |
| Aliskiren | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 1 | 17 participants |
| Ramipril | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score is Missing | 2 participants |
| Ramipril | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 1 | 19 participants |
| Ramipril | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 2 | 0 participants |
| Ramipril | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 3 | 0 participants |
| Ramipril | Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment | Score = 0 | 304 participants |
Secondary
Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)
Time frame: Weeks 8, 30 and End of Study (54 weeks)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | Week 8 | 50.8 Percentage of Participants |
| Aliskiren | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | Week 30 | 60.2 Percentage of Participants |
| Aliskiren | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | End of Study | 65.0 Percentage of Participants |
| Ramipril | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | Week 8 | 44.9 Percentage of Participants |
| Ramipril | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | Week 30 | 54.1 Percentage of Participants |
| Ramipril | Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target | End of Study | 56.1 Percentage of Participants |
Secondary
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
Time frame: 54 weeks
Population: Primary analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aliskiren | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Adenomatous polyps | 15.0 Percentage of Participants |
| Aliskiren | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Inflammatory polyps | 0.0 Percentage of Participants |
| Aliskiren | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Carcinoma | 0.0 Percentage of Participants |
| Aliskiren | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Hyperplastic polyps | 13.1 Percentage of Participants |
| Ramipril | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Carcinoma | 0.0 Percentage of Participants |
| Ramipril | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Adenomatous polyps | 17.3 Percentage of Participants |
| Ramipril | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Hyperplastic polyps | 10.2 Percentage of Participants |
| Ramipril | Percentage of Participants With Each of the Individual Components of Colonic Pathology | Inflammatory polyps | 0.3 Percentage of Participants |