Open Label Study Telmisartan and Amlodipine in Hypertension
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00614380
First received: January 28, 2008
Last updated: May 18, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: telmisartan/amlodipine 40/5 mg fixed combination Drug: telmisartan/amlodipine 80/5 mg fixed combination |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| Official Title: | An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Trough Seated Diastolic Blood Pressure (DBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ]The number of patients who reach the target DBP of <90mmHg
Secondary Outcome Measures:
- Trough Seated Systolic Blood Pressure (SBP) Control [ Time Frame: End of study (34 weeks or last value on treatment) ]The number of patients who reach the target SBP of <140mmHg
- Change From Baseline in Trough Seated Diastolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ]Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
- Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ]The difference between the last available troughs represents the additional reduction in DBP in this study
- Change From Baseline in Trough Seated Systolic Blood Pressure [ Time Frame: End of study (34 weeks or last value on treatment) ]Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
- Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [ Time Frame: End of study (34 weeks or last value on treatment) ]The difference between the last available troughs represents the additional reduction in SBP in this study
- Trough Seated DBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ]The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
- Trough Seated SBP Response [ Time Frame: End of study (34 weeks or last value on treatment) ]The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
- Trough Blood Pressure (BP) Normality Classes [ Time Frame: End of study (34 weeks or last value on treatment) ]The number of patients who reach predefined BP categories
- Time to First Additional Antihypertensive [ Time Frame: At any point during open-label treatment ]Time from first intake of medication to first intake of an antihypertensive other than the study drug
- Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [ Time Frame: At any point during open-label treatment ]The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
- Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ]Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
- Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [ Time Frame: At any point during open-label treatment ]Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
- Trough DBP Control Pre- and Post- Uptitration [ Time Frame: At any point during open-label treatment ]The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
| Enrollment: | 976 |
| Study Start Date: | January 2008 |
| Primary Completion Date: | March 2009 (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 |
Criteria
Inclusion Criteria:
- patients aged at least 18 years
- diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
- failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.
Exclusion Criteria:
- pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
- development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
- discontinuation from the preceding trial because of any adverse event or any other reason
- known or suspected secondary hypertension
- mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614380
Show 122 Study Locations
Show 122 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00614380 History of Changes |
| Other Study ID Numbers: | 1235.7, EUDRACT2007-002410-19 |
| Study First Received: | January 28, 2008 |
| Results First Received: | December 14, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP Canada: Health Canada (TPD) Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen S Finland: Finnish Medicines Agency France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE Korea, Republic of: Korea Food and Drug Administration (KFDA) Netherlands: Central Committee on Research involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Philippines: Department of Health, Republic of the Philippines South Africa: Medicines Control Council Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency Taiwan: Department of Health, Executive Yuan, Taiwan United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents Amlodipine Telmisartan Benzoates Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 18, 2013