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.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren/valsartan/HCTZ combination (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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 tolerability of the combination of aliskiren/valsartan/HCTZ.
Official title: A 54-Week, Open-Label, Multicenter Study to Assess the Long-Term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-Label Extension to Assess the Long-Term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/HCTZ.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
1. To assess (from the 12 month core study) the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg/valsartan 320 mg in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mgHg).
2. To assess the safety and tolerability of the triple combination of aliskiren/valsartan/HCTZ (SVH), using data obtained from both the core study and the 6 month extension study.
1. To assess the long-term blood pressure lowering efficacy of the combination of aliskiren/valsartan in patients with essential hypertension (msDBP >= 90 mmHg and < 110 mmHg) at the end of the 12 month core study.
2. To evaluate the proportion of patients achieving the blood pressure target of <140/90 mmHg at the end of the 12 month core study.
3. To assess the long-term blood pressure lowering efficacy of the triple combination of aliskiren/valsartan/HCTZ in patients with essential hypertension (msDBP >=90 mmHg and <=110 mmHg) at the end of the 6 month extension study.
4. To evaluate the proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of the 6 month extension study.
Minimum age: 18 Years.
Maximum age: N/A.
Inclusion Criteria: -
- Male and female outpatients 18 years of age and older.
- Patients who are eligible and able to participate in the study.
Patients will qualify to participate in the long-term extension based on:
- Their successful completion of the CSPV100A2301 Core study.
- Obtaining informed consent to participate in the extension study.
- Absence of ongoing severe adverse events at final visit in core study.
- Absence of hypotension (msSBP <100 mmHg or msDBP (<60 mmHg) or related events at final
visit in the core study.
- Absence of hypokalemia (clinical symptoms/signs or lab findings) at Visits 12 or 13.
- Severe hypertension.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Investigative Centers, Canada, Canada
Investigative Centers, Germany, Germany
Novartis Pharmaceuticals, various sites, East Hanover, New Jersey 07936, United States
Starting date: October 2006
Last updated: February 15, 2008