At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 947 enrolled
Drug / intervention
fixed dose combination of telmisartan+amlodipine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy
In Brief
A Phase 3 clinical trial evaluating fixed dose combination of telmisartan+amlodipine and amlodipine for Hypertension. Completed, enrolled 947 participants across 97 sites in 14 countries.
Detailed Summary
The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesAustralia, Austria, Bulgaria, Czechia, Ireland, Italy, New Zealand, Russia, Slovakia, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionOct 2008
TodayJul 2026
First PostedNov 5, 2007
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.7 years ago
Interventions
fixed dose combination of telmisartan+amlodipinedrug
amlodipinedrug