Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: telmisartan; Drug: amlodipine; Drug: telmisartan and amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860262

1235.20

2008-000873-40 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Enrollment: 858 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2. Age 18 years or older
3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)

Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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858 participants in 3 patient groups

telmisartan and amlodipine

Experimental group

Description:

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Treatment:

Drug: telmisartan and amlodipine

amlodipine

Active Comparator group

Description:

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Treatment:

Drug: amlodipine

telmisartan

Active Comparator group

Description:

telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Treatment:

Drug: telmisartan