Trial Outcomes & Findings for Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal (NCT NCT00865020)
NCT ID: NCT00865020
Last Updated: 2011-07-22
Results Overview
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
COMPLETED
PHASE4
822 participants
12 weeks, 13 weeks
2011-07-22
Participant Flow
1359 participants entered the Placebo Run-In phase which was 1-2 weeks in duration. Those participants completing the Placebo-Run-In Phase were randomized to receive either aliskiren 300 mg or telmisartan 80 mg.
Participant milestones
| Measure |
Aliskiren 300 mg
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Overall Study
STARTED
|
414
|
408
|
|
Overall Study
COMPLETED
|
365
|
357
|
|
Overall Study
NOT COMPLETED
|
49
|
51
|
Reasons for withdrawal
| Measure |
Aliskiren 300 mg
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
16
|
|
Overall Study
Adverse Event
|
9
|
14
|
|
Overall Study
Abnormal test procedure result(s)
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Protocol deviation
|
4
|
1
|
|
Overall Study
Administrative problems
|
0
|
2
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Randomized but discontinued
|
2
|
4
|
Baseline Characteristics
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
Baseline characteristics by cohort
| Measure |
Aliskiren 300 mg
n=414 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=408 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
Total
n=822 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.8 years
STANDARD_DEVIATION 11.46 • n=93 Participants
|
56.0 years
STANDARD_DEVIATION 11.91 • n=4 Participants
|
55.9 years
STANDARD_DEVIATION 11.68 • n=27 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=93 Participants
|
178 Participants
n=4 Participants
|
384 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
208 Participants
n=93 Participants
|
230 Participants
n=4 Participants
|
438 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks, 13 weeksPopulation: ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
Outcome measures
| Measure |
Aliskiren 300 mg
n=330 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=336 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
|
2.70 mmHg
Standard Error 0.466
|
6.51 mmHg
Standard Error 0.461
|
SECONDARY outcome
Timeframe: 12 weeks, 13 weeksPopulation: ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
Outcome measures
| Measure |
Aliskiren 300 mg
n=330 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=336 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
|
2.09 mmHg
Standard Error 0.328
|
4.21 mmHg
Standard Error 0.324
|
SECONDARY outcome
Timeframe: Baseline, 13 weeksPopulation: Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.
Outcome measures
| Measure |
Aliskiren 300 mg
n=336 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=339 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period
MASBP
|
-8.39 mmHg
Standard Error 0.542
|
-5.59 mmHg
Standard Error 0.539
|
|
Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period
MADBP
|
-5.05 mmHg
Standard Error 0.379
|
-3.44 mmHg
Standard Error 0.377
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 13 weeksPopulation: Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis. The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate. The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
Outcome measures
| Measure |
Aliskiren 300 mg
n=412 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=406 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Double-Blind Period (n1=374,371)
|
-15.22 mmHg
Standard Error 0.744
|
-14.64 mmHg
Standard Error 0.744
|
|
Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Treatment Interruption Period (n2=369,363)
|
1.26 mmHg
Standard Error 0.652
|
5.00 mmHg
Standard Error 0.658
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 13 weeksPopulation: Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis. The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate. The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
Outcome measures
| Measure |
Aliskiren 300 mg
n=412 Participants
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=406 Participants
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Double-Blind Period (n1=374,371)
|
-6.35 mmHg
Standard Error 0.453
|
-6.60 mmHg
Standard Error 0.453
|
|
Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period
Treatment Interruption Period (n2=369,363)
|
0.03 mmHg
Standard Error 0.388
|
2.69 mmHg
Standard Error 0.392
|
Adverse Events
Aliskiren 300 mg
Telmisartan 80 mg
Serious adverse events
| Measure |
Aliskiren 300 mg
n=411 participants at risk
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=403 participants at risk
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.25%
1/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.25%
1/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.24%
1/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.00%
0/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.25%
1/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.25%
1/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.25%
1/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
1/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
0.00%
0/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
Other adverse events
| Measure |
Aliskiren 300 mg
n=411 participants at risk
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Telmisartan 80 mg
n=403 participants at risk
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.6%
15/411 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
7.9%
32/403 • 13 weeks
Safety Set consisting of all participants who received at least one dose of double-blind study treatment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
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