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OpenTrials
Completed

NCT Number: NCT00939588

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 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren/ Valsartan

Drug

Telmisartan/ Ramipril

Drug

Primary outcomes

  1. Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone

    Time frame: 56 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
Jul 15, 2009
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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