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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

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ClinicalTrials.gov Identifier: NCT00939588
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren/ Valsartan Drug: Telmisartan/ Ramipril Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : July 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aliskiren and Valsartan Drug: Aliskiren/ Valsartan
Active Comparator: Telmisartan and Ramipril Drug: Telmisartan/ Ramipril



Primary Outcome Measures :
  1. Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II [ Time Frame: 56 days ]
  2. Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure [ Time Frame: 56 days ]
  3. Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan [ Time Frame: 56 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939588


Locations
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00939588     History of Changes
Other Study ID Numbers: CSPV100A2225
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
Aliskiren,
hypertension,
renin-angiotensin-aldosterone system

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Valsartan
Ramipril
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors