Phase 4
Completed N=822
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
Source: ClinicalTrials.gov NCT00865020 ↗Enrolled (actual)
822
Serious AEs
1.0%
Results posted
Jul 2011
Primary outcomePrimary: 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; 6.51 mmHg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 6.51 | — |
| SECONDARY 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; 4.21 | — |
| SECONDARY 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 |
-8.39; -5.59; -5.05; -3.44 | — |
| SECONDARY 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 |
-15.22; -14.64; 1.26; 5.00 | — |
| SECONDARY 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 |
-6.35; -6.60; 0.03; 2.69 | — |
Eligibility Criteria
Inclusion Criteria
- Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg
- 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg
Exclusion Criteria
- Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
- Patients with Type 1 diabetes mellitus
- Secondary hypertension of any etiology
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00865020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.