An open label extentsion study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 6 months -5 years old with hypertension.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005473-21-BE

Enrollment

Registered

2007-02-15

Start date

2007-04-23

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Hypertension

Interventions

Trade Name: Diovan 160 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: valsartan Concentration unit: mg/g milligram(s)/gram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who qualified and entered core study CVAL489K2303 2. Patients who participated in the core study CVAL489K2303, completed period 1 and were re-randomized in period 2 and continued for at least 3 days in period 2. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients who did not complete period 1 of the core study. 2. Patients who were re-reandomized in period 2 of core study but did not continue for =3 days in period 2 of the core study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy, safety and tolerability of long-term (6 months, core and extension protocols) use of valsartan in children 6 months to 5 years old with hypertension. ;Secondary Objective: ;Primary end point(s):	—

Countries

Belgium, France, Germany, Hungary, Italy, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026