At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 894 enrolled
Drug / intervention
Telmisartan +2 moredrug
Likely dose
Telmisartan 80mgfrom 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.
A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
In Brief
A Phase 4 clinical trial evaluating Telmisartan and Hydrochlorothiazide for Hypertension. Completed, enrolled 894 participants across 106 sites in 8 countries.
Detailed Summary
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBulgaria, China, France, Georgia, Romania, Russia, South Korea, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionApr 2010
TodayJul 2026
First PostedJun 23, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.0 years ago
Interventions
Telmisartandrug
Telmisartan 80mg
Telmisartandrug
Telmisartan 80mg
Hydrochlorothiazidedrug
Hydrochlorothiazide25mg