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A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

A 12-MONTH, RANDOMIZED, OPEN, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM SAFETY OF ALISKIREN 150 MG ONLY AND 300 MG ONLY, OR WITH THE ADDITIONAL ADDED HYDROCHLOROTHIAZIDE (12.5 MG OR 25 MG) IN PATIENTS WITH ESSENTIAL HYPERTENSION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-037-04
Enrollment
Unknown
Registered
2004-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Alisiken 150 mg Type of group
Aliskiren 150 mg administered alone is administered during the active treatment period of 52 weeks Group name:Alisiken 300 mg Type of group
Aliskiren 300 mg administered alone is administered during the active treatment period of 52 weeks

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study. absence of ongoing severe adverse events at Visit 10.

Exclusion criteria

Exclusion criteria: underage healthy people pregnant women

Design outcomes

Primary

MeasureTime frame
Outcome name:reporting of adverse events and serious adverse events, including deaths Measure:Assessment of safety through reporting of adverse events and serious adverse events, including deaths Timepoints:12 month—

Secondary

MeasureTime frame
Outcome name:blood pressure Measure:Change from baseline in mean diastolic blood pressure after 4 months Timepoints:4 months—

Countries

Belgium, Canada, Germany, Italy, Netherlands, Peru, Russian Federation, Switzerland, United Kindgdom

Outcome results

None listed

Source: REPEC (via WHO ICTRP)