FindTrial
Sign In

Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219180
Enrollment
1797
Registered
2005-09-22
Start date
2005-06-30
Completion date
2006-09-30
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

Brief summary

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in diastolic blood pressure after week 8—

Secondary

MeasureTime frame
Change from baseline in systolic blood pressure after week 8—
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks—
Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks—
Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026