An 8 week extension to a randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus anamlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - ND

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-001258-26-IT
• Date of registration: 15/03/2006
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: An 8 week extension to a randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus anamlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - ND
• Scientific title: An 8 week extension to a randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus anamlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - ND
• Date of first enrolment: 20/12/2005
• Target sample size: 1244
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001258-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

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

Key inclusion & exclusion criteria

Inclusion criteria:
-MSSPB 8805;140 mmHg, and/or MSDBP 8805;90 mmHg and currently treated with either valsartan 320 mg/HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at visit C -written informed consent to partecipate 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:
-Premature discontinuation in the core study or failure to comply with the core study protocol -Any patient that the investigator decides should not participate in the extension


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Essential hypertension
MedDRA version: 6.1 Level: PT Classification code 10015488

Intervention(s)

Trade Name: TAREG 160 160 MG 28 CPS
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Valsartan
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-

Product Name: amlodipine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Amlodipine
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

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

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

Primary end point(s): The study extension is designed to look at the additional blood pressure control MSSBP 140 mmHg and MSDBP 90 mmHg achieved by adding a third drug to the valsartan or amlodipine treatment strategy.

Secondary ID(s)

CVAH631B2406E1

2005-001258-26-ES