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Completed

NCT Number: NCT00558428

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.5.32004 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 at the date of signing the consent form
  • diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
  • failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
  • able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
  • willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).

Exclusion criteria

  • are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
  • known or suspected secondary hypertension
  • mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
  • any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
  • severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
  • bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
  • clinically relevant hyperkalaemia
  • uncorrected volume or sodium depletion.
  • primary aldosteronism.
  • hereditary fructose or lactose intolerance

Treatment and study plan

fixed dose combination of telmisartan+amlodipine

Drug

Amlodipine

Drug

Primary outcomes

  1. Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)

    Time frame: End of study (8 weeks or last value on treatment)

    Change from baseline to the end of study in trough DBP

  2. Number of Patients With Oedema

    Time frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)

    Patients from the treated set who experienced at least one case of general oedema.

Secondary outcomes

  1. Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)

    Time frame: End of study (8 weeks or last value on treatment)

    Change from baseline to the end of study in trough SBP

  2. Trough Seated Diastolic Blood Pressure Control

    Time frame: End of study (8 weeks or last value on treatment)

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

  3. Trough Seated DBP Response

    Time frame: End of study (8 weeks or last value on treatment)

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

  4. Trough Seated SBP Control

    Time frame: End of study (8 weeks or last value on treatment)

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

  5. Trough Seated SBP Response

    Time frame: End of study (8 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

  6. Trough Seated Blood Pressure (BP) Normality Classes

    Time frame: End of study (8 weeks or last value on treatment)

    The number of patients who reach predefined BP categories:

    • Optimal - SBP<120 and DBP<80 mmHg
    • Normal - SBP<130 and DBP<85 mmHg
    • High-normal - SBP<140 DBP<90 mmHg
    • Stage 1 hypertension - SBP<160 and DBP<100
    • Stage 2 hypertension SBP>=160 and DBP>=100 mmHg

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

Important dates

Study start
2007
Primary completion
2008
First posted
Nov 15, 2007
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.

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