A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
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
1 other identifier
interventional
336
7 countries
7
Brief Summary
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Jun 2005
Typical duration for phase_3 hypertension
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 11, 2020
February 1, 2011
1.9 years
September 12, 2005
February 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in diastolic blood pressure after 12 weeks
Secondary Outcomes (4)
Change from baseline in systolic blood pressure after 12 weeks
Change from baseline in systolic and diastolic blood pressure after 6 weeks
Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe hypertension
- Uncontrolled diabetes type I and II
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (7)
Investigative Site
Salisbury, North Carolina, 28144, United States
Investigative Site
Kortrijk, Belgium
Investigative Site
Bucharest, Romania
Investigative Site
Madrid, Spain
Investigative Site
Stockholm, Sweden
Novartis Pharmaceuticals
Basel, Switzerland
Investigative Site
Kiev, Ukraine
Related Publications (1)
Drummond W, Sirenko YM, Ramos E, Baek I, Keefe DL. Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 10.2165/11591970-000000000-00000.
PMID: 21846154DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
June 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 11, 2020
Record last verified: 2011-02