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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00926289 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan Drug: Hydrochlorothiazide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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) |
BP categories comprise:
| Enrollment: | 894 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Telmisartan
Telmisartan 80 mg
|
Drug: Telmisartan
Telmisartan 80mg
|
|
Experimental: Telmisartan/hydrochlorothiazide
Telmisartan80mg/Hydrochlorothiazide25mg
|
Drug: Telmisartan
Telmisartan 80mg
Drug: Hydrochlorothiazide
Hydrochlorothiazide25mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 106 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00926289 History of Changes |
| Other Study ID Numbers: | 502.550, 2008-007711-32 |
| Study First Received: | June 22, 2009 |
| Results First Received: | April 20, 2011 |
| Last Updated: | June 7, 2011 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency; China: State Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Georgia: Ministry of Health; Korea: Food and Drug Administration; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; United States: Food and Drug Administration |
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Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Telmisartan Benzoates Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |