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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 SBP compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and DBP>=100 mmHg).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan80mg Drug: Telmisartan80mg/hydrochlorothiazide25mg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 840 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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| Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 116 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 502.550, Eudra CT: 2008-007711-32 |
| Study First Received: | June 22, 2009 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00926289 History of Changes |
| 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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Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Benzoates Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide |
Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |