Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)
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|ClinicalTrials.gov Identifier: NCT00797316|
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : January 12, 2011
Last Update Posted : March 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Aliskiren Drug: Hydrochlorothiazide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||532 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension|
|Study Start Date :||November 2008|
|Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
Experimental: Aliskiren plus Hydrochlorothiazide
Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
Aliskiren 150 mg or 300 mg taken once daily in oral formDrug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.
Active Comparator: Aliskiren
Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Aliskiren 150 mg or 300 mg taken once daily in oral form
- Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline and Week 8 ]
- Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: 8 weeks ]
- Percentage of Participants With Blood Pressure Response at Week 8 [ Time Frame: 8 weeks ]Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.
- Percentage of Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: 8 weeks ]Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.
- Change From Baseline to Week 8 in Pulse Pressure [ Time Frame: Baseline and Week 8 ]
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): NCT00797316
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|