Completed
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.
What is being tested
Data Collection
Who is being recruted
Cardiovascular Diseases
+ Hypertension
+ Vascular Diseases
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 2008
Summary
Principal SponsorBoehringer Ingelheim
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2008
Actual date on which the first participant was enrolled.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.
Official TitleAn 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.
Principal SponsorBoehringer Ingelheim
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
976 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesHypertensionVascular Diseases
Criteria
3 inclusion criteria required to participate
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.
5 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 122 locations
Suspended
1235.7.3309B Boehringer Ingelheim Investigational Site
Angers, FranceOpen 1235.7.3309B Boehringer Ingelheim Investigational Site in Google MapsSuspended
1235.7.3309C Boehringer Ingelheim Investigational Site
Angers, FranceSuspended
1235.7.32004 Boehringer Ingelheim Investigational Site
Aywaille, BelgiumSuspended
1235.7.32010 Boehringer Ingelheim Investigational Site
Gozée, BelgiumCompleted122 Study Centers