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A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219063
Enrollment
844
Registered
2005-09-22
Start date
2005-02-28
Completion date
2006-03-31
Last updated
2017-05-17

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

Conditions

Hypertension

Keywords

Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide

Brief summary

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Interventions

DRUGaliskiren

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with essential hypertension * Patients who are eligible and able to participate in the study

Exclusion criteria

* Severe hypertension * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion

Design outcomes

Primary

MeasureTime frame
Change from baseline in diastolic blood pressure after 26 weeks

Secondary

MeasureTime frame
Change from baseline in systolic blood pressure after 26 weeks
Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks
Change from baseline in systolic blood pressure after 6 weeks and 12 weeks
Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

Countries

United States

Outcome results

None listed

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