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

NCT00860262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 858

Last updated 2014-05-20

Study results available
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Summary

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.

Conditions

Interventions

DRUG

amlodipine

amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w

DRUG

telmisartan

telmisartan 80mg for the 8w, no titration required

DRUG

telmisartan and amlodipine

telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Hungary
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860262 on ClinicalTrials.gov