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NCT00939588 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00939588
Other study ID # CSPV100A2225
Secondary ID
Status Completed
Phase Phase 2
First received July 9, 2009
Last updated November 16, 2016
Start date July 2009

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Aliskiren/ Valsartan

• Telmisartan/ Ramipril

Locations
Country Name City State
Russian Federation Novartis Investigative Site Moscow

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone 56 days No
Secondary Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II 56 days No
Secondary Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure 56 days No
Secondary Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan 56 days Yes
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