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 an amlodipine treatment strategy in achieving blood presure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-001258-26-FI
• Date of registration: 10/04/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• 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 an amlodipine treatment strategy in achieving blood presure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy
• 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 an amlodipine treatment strategy in achieving blood presure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy
• Date of first enrolment: 16/06/2006
• Target sample size: 224
• 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:
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:
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


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

Health Condition(s) or Problem(s) studied

Essential hypertension

Intervention(s)

Trade Name: Diovan
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: hydrochlorothiazide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: hydrochlorothiazide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

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

Primary Outcome(s)

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 primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at 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)

Secondary ID(s)

2005-001258-26-ES

CVAH631B2406 E1