Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5mg
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Amlodipine/Valsartan (Drug); amlodipine + valsartan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharma S.A.S S.A.S, Study Director, Affiliation: Sponsor GmbH
Novartis Pharma S.A.S, Study Chair, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 41-61-324-1111
Summary
Assess that for an equivalent brachial BP lowering, a fixed dose combination
Amlodipine/Valsartan based regimen reduces central aortic BP pressure to a larger extent than
an atenolol/amlodipine combination based regimen
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: central SBP measured at carotid artery level ( assessed with Sphygmocor system, Atcor Medical, Sydney, Australia) : difference in reduction of central SBP at baseline and at 24 weeks between the two arms
Secondary outcome: central pressure assessed with Sphygmocor system (Atcor Medical, Sydney, Australia)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients 18 years of age or older
- Hypertension defined by MSDBP > 90 and or MSSBP >140 mmHg, MSDBP > 80mmHg, or/and
MSSBP> 130mmHg if diabetes or chronic renal impairment uncontrolled under their
previous therapy, or untreated , or experiencing unacceptable side effects
- Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
- Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP >180
mmHg)
- Evidence of a secondary form of hypertension
- Type 1 diabetes mellitus
- History of congestive heart failure, unstable coronary insufficiency, life threatening
arrhythmia, significant valvular disease, second or third degree heart block etc.
Locations and Contacts
Novartis Pharmaceuticals, Phone: 41-61-324-1111
2 & 4 rue Lionel Terray BP 308, Rueil-Malmaison 92506, France; Recruiting
Novartis Pharmaceuticals, Phone: 41-61-324-1111
Additional Information
Starting date: January 2008
Last updated: May 30, 2008
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