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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

Enrollment: 88
Study Start Date: July 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren and Valsartan Drug: Aliskiren/ Valsartan
Active Comparator: Telmisartan and Ramipril 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
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, see Learn About Clinical Studies.

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 Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00939588     History of Changes
Other Study ID Numbers: CSPV100A2225
Study First Received: July 9, 2009
Last Updated: February 15, 2010
Health Authority: Russia: Ministry of Health of the Russian Federation

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

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

ClinicalTrials.gov processed this record on September 30, 2014