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


Tracking Information

Start Date  ICMJEJuly 2009
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: July 14, 2009)		Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00939588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 14, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJECompare 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
Official Title  ICMJEAn 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
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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJEBasic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEHypertension
Intervention  ICMJE
  • Drug: Aliskiren/ Valsartan
  • Drug: Telmisartan/ Ramipril
Study Arms / Comparison Groups
  • Aliskiren and Valsartan: Experimental
    Intervention: Drug: Aliskiren/ Valsartan
  • Telmisartan and Ramipril: Active Comparator
    Intervention: Drug: Telmisartan/ Ramipril

Recruitment Information

stimated Enrollment  ICMJE110
Completion Date 
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00939588
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECSPV100A2225
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis