Compare the Effect of Aliskiren Plus Valsartan Versus Angiotensin-Converting Enzyme Inhibitor (ACEi) Plus Angiotensin Receptor Blocker (ARB) [Ramipril Plus Telmisartan] on the Renin-Angiotensin-Aldosterone System (RAAS) in Hypertensive Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren/ Valsartan (Drug); Telmisartan/ Ramipril (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This study is designed as a mechanistic study to compare the effect of two different
combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and
ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate
hypertension.
Clinical Details
Official title: An 8 Week, Double-blind, Randomized, Parallel-group Study to Compare the Effect of Aliskiren 300mg + Valsartan 320mg vs. Telmisartan 80mg + Ramipril 10mg on Biomarkers of the Renin-angiotensin-aldosterone System in Moderate Hypertension
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone
Secondary outcome: Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin IICompare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females of non-childbearing potential, 18 to 65 years of age with moderate
hypertension
- Patients who are eligible and able to participate in the study
Exclusion criteria:
- Severe hypertension or secondary form of hypertension.
- Serum potassium > 5. 1 mEq/L (mmol/L)
- Heart failure
- Any history of hypertensive encephalopathy or cerebrovascular accident; any history
of TIA, myocardial infarction, coronary bypass surgery or percutaneous coronary
intervention
- Uncontrolled or life-threatening arrythmia
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Moscow, Russian Federation
Additional Information
Starting date: July 2009
Last updated: February 15, 2010
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