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OpenTrials
Completed

NCT Number: NCT00614380

Open Label Study Telmisartan and Amlodipine in Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.7.32004 Boehringer Ingelheim Investigational Site, Aywaille, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

telmisartan/amlodipine 40/5 mg fixed combination

Drug

telmisartan/amlodipine 80/5 mg fixed combination

Drug

Primary outcomes

  1. Trough Seated Diastolic Blood Pressure (DBP) Control

    Time frame: End of study (34 weeks or last value on treatment)

    The number of patients who reach the target DBP of <90mmHg

Secondary outcomes

  1. Trough Seated Systolic Blood Pressure (SBP) Control

    Time frame: End of study (34 weeks or last value on treatment)

    The number of patients who reach the target SBP of <140mmHg

  2. Change From Baseline in Trough Seated Diastolic Blood Pressure

    Time frame: End of study (34 weeks or last value on treatment)

    Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.

  3. Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7

    Time frame: End of study (34 weeks or last value on treatment)

    The difference between the last available troughs represents the additional reduction in DBP in this study

  4. Change From Baseline in Trough Seated Systolic Blood Pressure

    Time frame: End of study (34 weeks or last value on treatment)

    Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.

  5. Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7

    Time frame: End of study (34 weeks or last value on treatment)

    The difference between the last available troughs represents the additional reduction in SBP in this study

  6. Trough Seated DBP Response

    Time frame: End of study (34 weeks or last value on treatment)

    The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

  7. Trough Seated SBP Response

    Time frame: End of study (34 weeks or last value on treatment)

    The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

  8. Trough Blood Pressure (BP) Normality Classes

    Time frame: End of study (34 weeks or last value on treatment)

    The number of patients who reach predefined BP categories

  9. Time to First Additional Antihypertensive

    Time frame: At any point during open-label treatment

    Time from first intake of medication to first intake of an antihypertensive other than the study drug

  10. Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control

    Time frame: At any point during open-label treatment

    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment

  11. Additional Reduction in DBP by Use of Additional Antihypertensive Therapy

    Time frame: At any point during open-label treatment

    Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7

  12. Additional Reduction in SBP by Use of Additional Antihypertensive Therapy

    Time frame: At any point during open-label treatment

    Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7

  13. Trough DBP Control Pre- and Post- Uptitration

    Time frame: At any point during open-label treatment

    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 13, 2008
Registry last updated
Feb 13, 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.

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