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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00819767 |
This study will compare the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in SBP in patients with mild to moderate essential hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Aliskiren Drug: Valsartan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | An Eight-Week, Randomized, Double-Blind, Parallel-Group, Pilot Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg in Comparison With Valsartan 320 mg in Patients With Mild to Moderate Hypertension During Exercise After a Missed Dose |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Aliskiren 300mg
|
Drug: Aliskiren
Aliskiren 300mg
|
2: Active Comparator
Valsartan 320mg
|
Drug: Valsartan
Valsartan 320mg
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis | 862-778-8300 |
China | |
Investigative Site | |
Singapore, China | |
Czech Republic | |
Investigative Site | |
Prague, Czech Republic | |
Investigative Site | |
,Pardubice, Czech Republic | |
Hungary | |
Investigative Site | |
Budapest, Hungary | |
Investigative Site | |
Szentendre, Hungary | |
United Kingdom | |
Investigative Site | |
Leicester, United Kingdom |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CSPP100A2406 |
Study First Received: | January 7, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819767 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Singapore: Health Sciences Authority |
Hypertension systolic blood pressure exercise test |
cardiovascular disease aliskiren valsartan |
Vascular Diseases Valsartan Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |