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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00219102 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
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Scientific title:
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A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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336 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00219102 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Romania
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Spain
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Sweden
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Switzerland
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Ukraine
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Patients with essential hypertension
- Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
- Patients who are eligible and able to participate in the study
Exclusion Criteria
- Severe hypertension
- Uncontrolled diabetes type I and II
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Diabetes
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Intervention(s)
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Drug: aliskiren
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Primary Outcome(s)
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Change from baseline in diastolic blood pressure after 12 weeks
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Secondary Outcome(s)
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Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
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Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
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Change from baseline in systolic blood pressure after 12 weeks
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Change from baseline in systolic and diastolic blood pressure after 6 weeks
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Secondary ID(s)
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CSPP100A2310
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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