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Completed

NCT Number: NCT00624052

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

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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

1235.8.61003 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of essential hypertension

Exclusion criteria

  • pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
  • development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
  • discontinuation from the preceding trial.
  • known or suspected secondary hypertension.
  • mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
  • any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
  • clinically relevant hyperkalaemia.
  • uncorrected volume or sodium depletion.
  • primary aldosteronism.
  • hereditary fructose or lactose intolerance.
  • symptomatic congestive heart failure.
  • patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
  • any new drug or alcohol dependency since signing consent of the preceding trial.
  • concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
  • hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
  • known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
  • administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Treatment and study plan

fixed-dose combination of telmisartan 40mg+amlodipine 10mg

Drug

fixed-dose combination of telmisartan 80mg+amlodipine10mg

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 reached 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 reached the target SBP of >=140mmHg

  2. Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure

    Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6

  3. Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

    Time frame: Last available trough in NCT00553267 to 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 to End of Study in Trough Seated Systolic Blood Pressure

    Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6

  5. Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

    Time frame: Last available trough in NCT00624052 to 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 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: up to 34 weeks

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

  10. Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control

    Time frame: up to 34 weeks

    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: up to 34 weeks

    Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052

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

    Time frame: up to 34 weeks

    Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052

  13. Trough DBP Control Pre- and Post- Uptitration

    Time frame: up to 34 weeks

    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 26, 2008
Registry last updated
May 20, 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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