Trial Outcomes & Findings for A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension (NCT NCT00631917)
NCT ID: NCT00631917
Last Updated: 2011-07-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
774 participants
Primary outcome timeframe
54 weeks
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
375
|
399
|
|
Overall Study
COMPLETED
|
287
|
291
|
|
Overall Study
NOT COMPLETED
|
88
|
108
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
34
|
45
|
|
Overall Study
Abnormal laboratory value(s)
|
2
|
1
|
|
Overall Study
Abnormal test procedure result(s)
|
3
|
2
|
|
Overall Study
Unsatisfactory therapeutic effect
|
8
|
14
|
|
Overall Study
No longer required study drug
|
0
|
1
|
|
Overall Study
Protocol deviation
|
6
|
5
|
|
Overall Study
Subject withdrew consent
|
25
|
33
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Administrative problems
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
Baseline characteristics by cohort
| Measure |
Aliskiren
n=375 Participants
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.
|
Ramipril
n=399 Participants
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.
|
Total
n=774 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 6.99 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 6.65 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
|
Age, Customized
< 65 years
|
299 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
612 Participants
n=5 Participants
|
|
Age, Customized
65 years and greater
|
76 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 54 weeksPopulation: Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.
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.
Outcome measures
| Measure |
Aliskiren
n=314 Participants
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.
|
Ramipril
n=325 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Colonic Pathology
|
25.5 Percentage of participants
|
25.1 Percentage of participants
|
PRIMARY outcome
Timeframe: 54 weeksPopulation: Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.
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.
Outcome measures
| Measure |
Aliskiren
n=314 Participants
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.
|
Ramipril
n=325 Participants
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.
|
|---|---|---|
|
Summary of the End of Study Colonoscopy Results
Inflammation for any biopsy samples-Missing
|
0.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Complete colonoscopy performed
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Was cecum reached in procedure
|
99.7 Percentage of Participants
|
100 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Photos obtained
|
99.4 Percentage of Participants
|
99.7 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Took drug affecting bowel function
|
0.0 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Took low dose aspirin during wk prior to procedure
|
4.8 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Adequacy of bowel preparation - Optimal
|
72.3 Percentage of Participants
|
73.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Adequacy of bowel preparation - Suboptimal
|
27.4 Percentage of Participants
|
25.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Adequacy of bowel preparation - Inadequate
|
0.3 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Colonoscopy prep given- PEG containing solution
|
96.8 Percentage of Participants
|
97.2 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Colonoscopy prep given - Other
|
3.2 Percentage of Participants
|
2.8 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Occurrence of colon polyps
|
29.6 Percentage of Participants
|
26.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with polyps-Cecum/ascending
|
11.8 Percentage of Participants
|
11.4 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with polyps-Transverse
|
6.1 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with polyps-Descending/sigmoid
|
12.1 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with polyps-Rectum
|
8.0 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of polyps-Cecum/ascending
|
1.3 Percentage of Participants
|
1.2 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of polyps-Transverse
|
1.2 Percentage of Participants
|
1.4 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of polyps-Descending/sigmoid
|
1.5 Percentage of Participants
|
1.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of polyps-Rectum
|
1.6 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Polyps were completely resected-Cecum/ascending
|
11.8 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Polyps were completely resected-Transverse
|
6.1 Percentage of Participants
|
4.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Polyps were completely resected-Descending/sigmoid
|
12.1 Percentage of Participants
|
11.7 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Polyps were completely resected-Rectum
|
7.6 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Photo taken for polyps-Cecum/ascending
|
11.8 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Photo taken for polyps-Transverse
|
5.7 Percentage of Participants
|
4.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Photo taken for polyps-Descending/sigmoid
|
10.8 Percentage of Participants
|
10.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Photo taken for polyps-Rectum
|
7.6 Percentage of Participants
|
6.2 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mucosal abnormalities for colitis
|
1.3 Percentage of Participants
|
1.5 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with colitis-Cecum/ascending
|
0.6 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with colitis-Transverse
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with colitis-Descending/sigmoid
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Patients with colitis-Rectum
|
0.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis biopsied-Cecum/ascending
|
0.6 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis biopsied-Transverse
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis biopsied-Descending/sigmoid
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis biopsied-Rectum
|
0.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis photographed-Cecum/ascending
|
0.6 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis photographed-Transverse
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis photographed-Descending/sigmoid
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Area of colitis photographed-Rectum
|
0.6 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Normal mucosal biopsies collected-Cecum
|
99.4 Percentage of Participants
|
99.7 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of normal mucosal biopsies-Cecum
|
3.0 Percentage of Participants
|
3.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Mean number of normal mucosal biopsies-Rectum
|
3.0 Percentage of Participants
|
3.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Malignance for any biopsy samples-Yes
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Malignance for any biopsy samples-No
|
99.4 Percentage of Participants
|
98.8 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Malignance for any biopsy samples-Missing
|
0.6 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Inflammation for any biopsy samples-Yes
|
1.0 Percentage of Participants
|
0.6 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Inflammation for any biopsy samples-No
|
98.4 Percentage of Participants
|
98.8 Percentage of Participants
|
|
Summary of the End of Study Colonoscopy Results
Normal mucosal biopsies collected-Rectum
|
99.7 Percentage of Participants
|
99.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: Primary analysis set
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.
Outcome measures
| Measure |
Aliskiren
n=314 Participants
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.
|
Ramipril
n=325 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Hyperplastic polyps
|
13.1 Percentage of Participants
|
10.2 Percentage of Participants
|
|
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Inflammatory polyps
|
0.0 Percentage of Participants
|
0.3 Percentage of Participants
|
|
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Adenomatous polyps
|
15.0 Percentage of Participants
|
17.3 Percentage of Participants
|
|
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Carcinoma
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: Primary analysis set
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.
Outcome measures
| Measure |
Aliskiren
n=314 Participants
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.
|
Ramipril
n=325 Participants
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.
|
|---|---|---|
|
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Score = 1
|
17 participants
|
19 participants
|
|
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Score = 2
|
0 participants
|
0 participants
|
|
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Score is Missing
|
2 participants
|
2 participants
|
|
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Score = 0
|
295 participants
|
304 participants
|
|
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Score = 3
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 8, 30 and End of Study (54 weeks)Population: Full analysis set
The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)
Outcome measures
| Measure |
Aliskiren
n=374 Participants
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.
|
Ramipril
n=394 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
Week 8
|
50.8 Percentage of Participants
|
44.9 Percentage of Participants
|
|
Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
Week 30
|
60.2 Percentage of Participants
|
54.1 Percentage of Participants
|
|
Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
End of Study
|
65.0 Percentage of Participants
|
56.1 Percentage of Participants
|
Adverse Events
Aliskiren
Serious events: 28 serious events
Other events: 163 other events
Deaths: 0 deaths
Ramipril
Serious events: 22 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren
n=375 participants at risk
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.
|
Ramipril
n=399 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.27%
1/375
|
0.00%
0/399
|
|
Cardiac disorders
Coronary artery disease
|
0.80%
3/375
|
0.25%
1/399
|
|
Cardiac disorders
Myocardial infarction
|
0.80%
3/375
|
0.50%
2/399
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/375
|
0.00%
0/399
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.27%
1/375
|
0.00%
0/399
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/375
|
0.25%
1/399
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/375
|
0.25%
1/399
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/375
|
0.50%
2/399
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.27%
1/375
|
0.00%
0/399
|
|
General disorders
Non-cardiac chest pain
|
0.53%
2/375
|
0.00%
0/399
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/375
|
0.25%
1/399
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/375
|
0.00%
0/399
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/375
|
0.25%
1/399
|
|
Immune system disorders
Type III immune complex mediated reaction
|
0.27%
1/375
|
0.00%
0/399
|
|
Infections and infestations
Appendicitis
|
0.27%
1/375
|
0.00%
0/399
|
|
Infections and infestations
Arthritis bacterial
|
0.27%
1/375
|
0.00%
0/399
|
|
Infections and infestations
Bronchitis
|
0.00%
0/375
|
0.25%
1/399
|
|
Infections and infestations
Staphylococcal infection
|
0.27%
1/375
|
0.00%
0/399
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/375
|
0.25%
1/399
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.27%
1/375
|
0.00%
0/399
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/375
|
0.25%
1/399
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.27%
1/375
|
0.00%
0/399
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.27%
1/375
|
0.00%
0/399
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/375
|
0.25%
1/399
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/375
|
0.25%
1/399
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.53%
2/375
|
0.00%
0/399
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/375
|
0.25%
1/399
|
|
Nervous system disorders
Facial palsy
|
0.27%
1/375
|
0.00%
0/399
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/375
|
0.25%
1/399
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/375
|
0.25%
1/399
|
|
Nervous system disorders
Syncope
|
0.53%
2/375
|
0.00%
0/399
|
|
Nervous system disorders
Transient ischaemic attack
|
0.27%
1/375
|
0.50%
2/399
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/375
|
0.25%
1/399
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/375
|
0.25%
1/399
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/375
|
0.25%
1/399
|
|
Renal and urinary disorders
Renal failure acute
|
0.27%
1/375
|
0.00%
0/399
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.27%
1/375
|
0.00%
0/399
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.27%
1/375
|
0.00%
0/399
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/375
|
0.25%
1/399
|
|
Vascular disorders
Aortic dissection
|
0.27%
1/375
|
0.00%
0/399
|
|
Vascular disorders
Arteritis
|
0.00%
0/375
|
0.25%
1/399
|
|
Vascular disorders
Hypertension
|
0.80%
3/375
|
0.00%
0/399
|
|
Vascular disorders
Hypertensive crisis
|
0.53%
2/375
|
0.00%
0/399
|
|
Vascular disorders
Hypertensive emergency
|
0.27%
1/375
|
0.00%
0/399
|
Other adverse events
| Measure |
Aliskiren
n=375 participants at risk
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.
|
Ramipril
n=399 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
28/375
|
6.0%
24/399
|
|
Gastrointestinal disorders
Nausea
|
5.1%
19/375
|
3.8%
15/399
|
|
General disorders
Oedema peripheral
|
7.5%
28/375
|
5.0%
20/399
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
19/375
|
5.3%
21/399
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
27/375
|
6.5%
26/399
|
|
Infections and infestations
Urinary tract infection
|
5.6%
21/375
|
2.5%
10/399
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
17/375
|
5.5%
22/399
|
|
Nervous system disorders
Dizziness
|
6.1%
23/375
|
7.3%
29/399
|
|
Nervous system disorders
Headache
|
10.9%
41/375
|
13.5%
54/399
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
14/375
|
12.0%
48/399
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER