Trials / Completed
CompletedNCT00865020
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
A Twelve-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Prolonged Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg in Mild to Moderate Hypertensive Patients With the 24-hour Ambulatory Blood Pressure Measurement After 1 Week of Treatment Withdrawal Study Acronym: ASSERTIVE - AliSkiren Study of Profound antihypERtensive Efficacy in hyperTensIVE Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 822 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aliskiren | Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks. |
| DRUG | Telmisartan | Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks. |
| DRUG | Placebo to Aliskiren | Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week. |
| DRUG | Placebo to Telmisartan | Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-06-01
- Completion
- 2010-06-01
- First posted
- 2009-03-19
- Last updated
- 2011-07-22
- Results posted
- 2011-07-22
Locations
16 sites across 16 countries: Brazil, Canada, Ecuador, Germany, Hungary, Malaysia, Mexico, Panama, Philippines, Singapore, Slovakia, South Korea, Spain, Turkey (Türkiye), United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT00865020. Inclusion in this directory is not an endorsement.