Open Label Study Telmisartan and Amlodipine in Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: telmisartan/amlodipine 80/5 mg fixed combination; Drug: telmisartan/amlodipine 40/5 mg fixed combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00614380

EUDRACT2007-002410-19

1235.7

Details and patient eligibility

About

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.

Enrollment: 976 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients aged at least 18 years
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion criteria

1. 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
2. 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
3. discontinuation from the preceding trial because of any adverse event or any other reason
4. known or suspected secondary hypertension
5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit