At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 706 enrolled
Drug / intervention
Telmisartan 80 +2 moredrug
Likely dose
Telmisartan 80 80 mgfrom 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 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.
In Brief
A Phase 3 clinical trial evaluating Telmisartan 80 and Amlodipine 10 for Hypertension. Completed, enrolled 706 participants across 65 sites in 9 countries.
Detailed Summary
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Mexico, Netherlands, Slovakia, South Africa, South Korea, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedApr 2009
Primary CompletionMay 2010
TodayJul 2026
First PostedApr 8, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.2 years ago
Interventions
Telmisartan 80drug
Telmisartan 80 mg
Amlodipine 10drug
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
Amlodipine 10drug
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10