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Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765674
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Aliskiren
Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)
Drug: Placebo
Enrollment 1191
Recruitment Details  
Pre-assignment Details In the single-blind period, 1909 patients were enrolled, 1189 completed, and 720 discontinued. Of the 1191 randomized patients, 2 patients were randomized by error and discontinued in the single-blind period without taking double-blind medication.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Period Title: Overall Study
Started 287 298 [1] 296 310 [1]
Completed 266 276 279 285
Not Completed 21 22 17 25
Reason Not Completed
Adverse Event             7             2             8             11
Abnormal Laboratory Value(s)             0             0             1             0
Abnormal Test Procedure Result(s)             1             3             1             2
Lack of Efficacy             2             3             1             2
Protocol Violation             2             0             1             0
Withdrawal by Subject             5             7             3             8
Lost to Follow-up             4             6             2             1
Randomized in Error - No Study Drug             0             1             0             1
[1]
1 patient was randomized in error and discontinued without taking any double-blind study medication.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide Total
Hide Arm/Group Description Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed Total of all reporting groups
Overall Number of Baseline Participants 287 298 296 310 1191
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 287 participants 298 participants 296 participants 310 participants 1191 participants
54.4  (11.33) 55.5  (10.75) 55.1  (10.86) 55.4  (10.54) 55.1  (10.86)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 298 participants 296 participants 310 participants 1191 participants
< 65 years 237 242 233 251 963
>=65 years 50 56 63 59 228
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 298 participants 296 participants 310 participants 1191 participants
Female
115
  40.1%
123
  41.3%
110
  37.2%
123
  39.7%
471
  39.5%
Male
172
  59.9%
175
  58.7%
186
  62.8%
187
  60.3%
720
  60.5%
1.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Hide Description Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description:
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Overall Number of Participants Analyzed 282 296 295 308
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-31.37  (0.90) -27.99  (0.88) -30.77  (0.88) -37.92  (0.86)
2.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Hide Description Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description:
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Overall Number of Participants Analyzed 282 296 295 308
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-18.03  (0.57) -14.32  (0.55) -17.03  (0.55) -20.63  (0.54)
3.Secondary Outcome
Title Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)
Hide Description Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description:
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Overall Number of Participants Analyzed 283 296 295 192
Measure Type: Number
Unit of Measure: Percentage of patients
41.3 33.1 39.0 62.3
4.Secondary Outcome
Title Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)
Hide Description Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population: All randomized patients who had post-baseline efficacy measurements.
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description:
Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
Overall Number of Participants Analyzed 138 155 136 147
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic BP -20.30  (0.52) -16.27  (0.51) -18.67  (0.53) -25.29  (0.51)
Diastolic BP -13.29  (0.36) -9.57  (0.35) -11.20  (0.37) -15.90  (0.35)
Time Frame During the 8 week double blind treatment
Adverse Event Reporting Description Safety Set. All patients who received double-blind trial medication.
 
Arm/Group Title Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Hide Arm/Group Description Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
All-Cause Mortality
Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/287 (1.05%)   2/297 (0.67%)   2/295 (0.68%)   6/309 (1.94%) 
Cardiac disorders         
Acute coronary syndrome  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Arrhythmia supraventricular  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Endocrine disorders         
Goitre  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Infections and infestations         
Hepatitis A  1  1/287 (0.35%)  0/297 (0.00%)  0/295 (0.00%)  0/309 (0.00%) 
Tubo-ovarian abscess  1  0/287 (0.00%)  1/297 (0.34%)  0/295 (0.00%)  0/309 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/287 (0.00%)  0/297 (0.00%)  1/295 (0.34%)  0/309 (0.00%) 
Syncope  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Pregnancy, puerperium and perinatal conditions         
Ectopic pregnancy  1  1/287 (0.35%)  0/297 (0.00%)  0/295 (0.00%)  0/309 (0.00%) 
Psychiatric disorders         
Psychosomatic disease  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Renal and urinary disorders         
Stress urinary incontinence  1  0/287 (0.00%)  1/297 (0.34%)  0/295 (0.00%)  0/309 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  0/287 (0.00%)  0/297 (0.00%)  1/295 (0.34%)  0/309 (0.00%) 
Nasal septum deviation  1  1/287 (0.35%)  0/297 (0.00%)  0/295 (0.00%)  0/309 (0.00%) 
Vascular disorders         
Hypertension  1  0/287 (0.00%)  0/297 (0.00%)  0/295 (0.00%)  1/309 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aliskiren / Amlodipine Aliskiren / Hydrochlorothiazide Amlodipine / Hydrochlorothiazide Aliskiren / Amlodipine / Hydrochlorothiazide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/287 (11.15%)   17/297 (5.72%)   26/295 (8.81%)   29/309 (9.39%) 
General disorders         
Oedema peripheral  1  23/287 (8.01%)  6/297 (2.02%)  12/295 (4.07%)  22/309 (7.12%) 
Nervous system disorders         
Headache  1  9/287 (3.14%)  12/297 (4.04%)  15/295 (5.08%)  11/309 (3.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00765674     History of Changes
Other Study ID Numbers: CSAH100A2302
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: January 12, 2011
Results First Posted: May 9, 2011
Last Update Posted: May 9, 2011