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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00939588

Enrollment

Registered

2009-07-15

Start date

2009-07-31

Completion date

Unknown

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Aliskiren,, hypertension,, renin-angiotensin-aldosterone system

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.

Interventions

DRUGAliskiren/ Valsartan

DRUGTelmisartan/ Ramipril

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on 24-hour urinary aldosterone	56 days

Secondary

Measure	Time frame
Assess safety and tolerability of aliskiren + valsartan and ramipril + telmisartan	56 days
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on Plasma Renin Activity (PRA)and angiotensin II	56 days
Compare the effects of aliskiren + valsartan vs ramipril + telmisartan on mean sitting systolic and diastolic blood pressure	56 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026