Extensión de 8 semanas de duración del estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de control activo, de 14 semanas de duración para evaluar la efectividad de la estrategia de tratamiento de valsartan con respecto a amlodipino para alcanzar un control de la presión arterial en pacientes con hipertensión grado 1 o grado 2 o no controlada actualmente en monoterapia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001258-26-ES

Enrollment

224

Registered

2006-01-23

Start date

2006-03-14

Completion date

Unknown

Last updated

2021-09-07

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

Conditions

Essential hypertension

Interventions

Product Name: valsartan Pharmaceutical Form: Capsule, hard INN or Proposed INN: valsartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- Product Name: hydroc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. MSSBP = 140 mm Hg, and/or MSDBP = 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/ HCTZ 25 mg at Visit C 2. Written informed consent to participate in the extension study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Premature discontinuation in the core study or failure to comply with the core study protocol 2. Any patient that the investigator decides should not participate in the extension study

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg/HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at (Visit 7, week 18) and end of study (Visit 8, week 22);Secondary Objective: To evaluate the overall number of patients who reached BP control on the valsartan compared to the amlodipine treatment strategy at end of study including the core and extension phase To evaluate safety and tolerability, measured by rate of adverse events between baseline (Visit C, week 14) and end of study (Visit 8, week 22);Primary end point(s): The primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at week 22	—

Measure

Time frame

Main Objective: To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg/HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at (Visit 7, week 18) and end of study (Visit 8, week 22);Secondary Objective: To evaluate the overall number of patients who reached BP control on the valsartan compared to the amlodipine treatment strategy at end of study including the core and extension phase To evaluate safety and tolerability, measured by rate of adverse events between baseline (Visit C, week 14) and end of study (Visit 8, week 22);Primary end point(s): The primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at week 22

—

Countries

Denmark, Finland, Germany, Ireland, Italy, Spain, United Kingdom

Outcome results

None listed

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