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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 II

Compare 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

Page last updated: August 23, 2015

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