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Completed

NCT Number: NCT00558064

Filtered Trial for Amlodipine Non-responder

To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1235.13.037 Boehringer Ingelheim Investigational Site, Azumino, Nagano, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Essential hypertensive patients satisfying all of the following criteria;
  • Male or Female
  • Age > 20 years
  • Outpatient
  • Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
  • Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

Exclusion criteria

  • Taking four or more anti-hypertensive medications
  • Secondary hypertension
  • Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
  • Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
  • Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
  • History of myocardial infarction or cardiac surgery within last 6 months
  • History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
  • History of unstable angina within last 3 months
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
  • History of stroke or transient ischemic attack within last 6 months
  • History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
  • Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
  • Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
  • Hepatic and/or renal dysfunction
  • Diagnosed biliary atresia or cholestasis
  • Hyperkalemia
  • Dehydration
  • Sodium deficiency
  • Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Patients who cannot change to the restricted administration and dosage during study period
  • Pre-menopausal women who meet any one of the following 1 - 3:
  • Pregnant or possibly pregnant (1)
  • Nursing (2)
  • Desire to become pregnant during study period (3)
  • Drug or alcohol dependency
  • Complication of malignant tumour or a disease requiring immunosuppressants
  • Compliance of < 80% or > 120% during the run-in period
  • Receiving any investigational therapy within 3 months
  • Judged to be inappropriate by the investigator or the sub-investigator

Treatment and study plan

telmisartan+amlodipine

Drug

Amlodipine

Drug

Primary outcomes

  1. Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)

    Time frame: Baseline and 8 Weeks

    The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

Secondary outcomes

  1. Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)

    Time frame: Baseline and 8 Weeks

    The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

  2. Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)

    Time frame: 8 weeks

    Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

  3. Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)

    Time frame: 8 weeks

    Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

  4. Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)

    Time frame: 8 weeks

    Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks

  5. Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks

    Time frame: 8 weeks

    Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)

  6. Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)

    Time frame: 8 weeks

    Optimal, normal, high normal blood pressure were defined as follows:

    • Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
    • Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
    • High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg
    • No: SBP >= 140 mmHg and DPB >= 90 mmHg

  7. Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG

    Time frame: First administration of randomised treatment to 24 hours post last dose of randomised treatment

    Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Nov 14, 2007
Registry last updated
Jul 8, 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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