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

This study is not yet open for participant recruitment.

Verified by Novartis, July 2009

First Received: July 9, 2009 Last Updated: July 14, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00939588

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren/ Valsartan Drug: Telmisartan/ Ramipril	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aldosterone Ramipril Valsartan Telmisartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	July 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Aliskiren and Valsartan: Experimental	Drug: Aliskiren/ Valsartan
Telmisartan and Ramipril: Active Comparator	Drug: Telmisartan/ Ramipril

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939588

Locations

Russian Federation
Novartis Investigative Site
Moscow, Russian Federation

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPV100A2225
Study First Received:	July 9, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00939588 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Novartis:

Aliskiren,
hypertension,
renin-angiotensin-aldosterone system

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010