Text Size

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 has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00939588
First received: July 9, 2009
Last updated: February 15, 2010
Last verified: February 2010
History of Changes

July 9, 2009
February 15, 2010
July 2009
December 2009   (final data collection date for primary outcome measure)
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00939588 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Hypertension
  • Drug: Aliskiren/ Valsartan
  • Drug: Telmisartan/ Ramipril
  • Experimental: Aliskiren and Valsartan
    Intervention: Drug: Aliskiren/ Valsartan
  • Active Comparator: Telmisartan and Ramipril
    Intervention: Drug: Telmisartan/ Ramipril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00939588
CSPV100A2225
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP