Status:
COMPLETED
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and t...
Eligibility Criteria
Inclusion
- Male and female outpatients 18 years of age and older.
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)
- Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
Exclusion
- Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
- Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00386607
Start Date
October 1 2006
End Date
July 1 2008
Last Update
February 10 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigative Centers
San Diego, California, United States
2
Investigative Centers
Canada, Canada
3
Investigative Centers
Germany, Germany
4
Investigative Centers
Netherlands, Netherlands