Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.
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|ClinicalTrials.gov Identifier: NCT00343551|
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: Aliskiren||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||654 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Nine-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg Compared to Irbesartan 300 mg and Ramipril 10 mg in the Setting of a Missed Dose in Patients With Essential Hypertension|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||January 2007|
- Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg.
- from baseline.
- Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg.
- efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change
- from baseline following a missed dose
- efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose
- efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group.
- efficacy on the daytime and nighttime MASBP and MADBP change from baseline, following the last active dose prior to introducing a missed dose in any treatment group.
- safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343551
|Investigative Centers, Germany|
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|