COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939588
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : November 18, 2016
Information provided by:

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

Layout table for study information
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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00939588

Layout table for location information
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00939588    
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:
renin-angiotensin-aldosterone system
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors