Skip to main content
OpenTrials
Completed

NCT Number: NCT01204398

Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.31.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged at least 18 years at the date of signing the consent form
  • For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
  • 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

Exclusion criteria

  • mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
  • any clinically significant hepatic impairment
  • severe renal impairment
  • bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
  • current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
  • other conditions or situations that could put potential participants at unacceptable risk due to participation in this study

Treatment and study plan

telmisartan+amlodipine fixed dose combination

Drug

after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Primary outcomes

  1. DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean

    Time frame: 8 weeks

    ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.

Secondary outcomes

  1. Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing

    Time frame: 8 weeks

    Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5

  2. Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment

    Time frame: 8 weeks

    Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.

  3. Change From Baseline to End of Study in DBP and SBP

    Time frame: 8 weeks

    Manually measured in-clinic DBP and SBP

  4. ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing

    Time frame: 0 and 8 weeks

    DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment

  5. Treatment Emergent Adverse Events

    Time frame: 8 weeks

    Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events

  6. Change From Baseline to End of Study in In-clinic Pulse Rate

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension

Important dates

Study start
2010
Primary completion
2011
First posted
Sep 17, 2010
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.