A Phase 4 interventional study of Aliskiren and Telmisartan in Hypertension, sponsored by Novartis. Completed at 16 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Novartis · Phase 4, Interventional, and Treatment
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.
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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.
Drug: Aliskiren · Drug: Placebo to Aliskiren
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.
Drug: Telmisartan · Drug: Placebo to Telmisartan
Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.
Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.
Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.
Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.
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
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.
Time frame: 12 weeks, 13 weeks
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
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.
Time frame: 12 weeks, 13 weeks
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
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.
Time frame: Baseline, 13 weeks
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
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.
Time frame: Baseline, 12 weeks, 13 weeks
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
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.
Time frame: Baseline, 12 weeks, 13 weeks
| Milestone | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| Started | 414 | 408 |
| Completed | 365 | 357 |
| Not completed | 49 | 51 |
| Withdrew: Withdrawal by subject | 22 | 16 |
| Withdrew: Adverse event | 9 | 14 |
| Withdrew: Abnormal test procedure result(s) | 6 | 8 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Protocol deviation | 4 | 1 |
| Withdrew: Administrative problems | 0 | 2 |
| Withdrew: Abnormal laboratory value(s) | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Randomized but discontinued | 2 | 4 |
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.
| mmHg | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| 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 ± 0.466 | 6.51 ± 0.461 |
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.
| mmHg | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| 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 ± 0.328 | 4.21 ± 0.324 |
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.
| mmHg | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| MASBP | -8.39 ± 0.542 | -5.59 ± 0.539 |
| MADBP | -5.05 ± 0.379 | -3.44 ± 0.377 |
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.
| mmHg | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| Double-Blind Period (n1=374,371) | -15.22 ± 0.744 | -14.64 ± 0.744 |
| Treatment Interruption Period (n2=369,363) | 1.26 ± 0.652 | 5.00 ± 0.658 |
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.
| mmHg | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| Double-Blind Period (n1=374,371) | -6.35 ± 0.453 | -6.60 ± 0.453 |
| Treatment Interruption Period (n2=369,363) | 0.03 ± 0.388 | 2.69 ± 0.392 |
Collected over 13 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aliskiren 300 mg | — | 3/411 (0.7%) | 15/411 (3.6%) |
| Telmisartan 80 mg | — | 5/403 (1.2%) | 32/403 (7.9%) |
| Event | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/411 | 1/403 |
| Angina unstableCardiac disorders | 0/411 | 1/403 |
| DiverticulitisInfections and infestations | 0/411 | 1/403 |
| Femur fractureInjury, poisoning and procedural complications | 0/411 | 1/403 |
| Ischaemic strokeNervous system disorders | 0/411 | 1/403 |
| Pancreatitis acuteGastrointestinal disorders | 1/411 | 0/403 |
| Transient ischaemic attackNervous system disorders | 1/411 | 0/403 |
| Event | Aliskiren 300 mg | Telmisartan 80 mg |
|---|---|---|
| HeadacheNervous system disorders | 15/411 | 32/403 |
| Age Continuous(years) | Aliskiren 300 mg | Telmisartan 80 mg | Total |
|---|---|---|---|
| Mean | 55.8 ± 11.46 | 56.0 ± 11.91 | 55.9 ± 11.68 |
| Sex: Female, Male(Participants) | Aliskiren 300 mg | Telmisartan 80 mg | Total |
|---|---|---|---|
| Female | 206 | 178 | 384 |
| Male | 208 | 230 | 438 |
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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