An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Telmisartan80mg+Amlodipine 5mg; Drug: amlodipine 5mg; Drug: Telmisartan80mg+Amlodipine5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103960

1235.29

Details and patient eligibility

About

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosis of essential hypertension
2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
3. provision of written informed consent

Exclusion criteria

1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 2 patient groups

Telmisartan80mg+Amlodipine5mg

Experimental group

Description:

combination therapy

Treatment:

Drug: Telmisartan80mg+Amlodipine5mg

amlodipine 5 mg

Active Comparator group

Description:

Monotherapy

Treatment:

Drug: Telmisartan80mg+Amlodipine 5mg

Drug: amlodipine 5mg