NCT00939588
Completed
Phase 2
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
ConditionsHypertension
Overview
- Phase
- Phase 2
- Intervention
- Aliskiren/ Valsartan
- Conditions
- Hypertension
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
Aliskiren and Valsartan
Intervention: Aliskiren/ Valsartan
Telmisartan and Ramipril
Intervention: Telmisartan/ Ramipril
Outcomes
Primary Outcomes
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone
Time Frame: 56 days
Secondary Outcomes
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II(56 days)
- Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure(56 days)
- Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan(56 days)
Study Sites (1)
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