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Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring

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ClinicalTrials.gov Identifier: NCT02242318
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering diastolic blood pressure in patients who missed a dose of their medication, as measured by ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Valsartan Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring
Study Start Date : September 2001
Actual Primary Completion Date : September 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan
low dose for two weeks, then up titration to high dose, once daily
Drug: Telmisartan
Drug: Placebo
Active Comparator: Valsartan
low dose for two weeks, then up titration to high dose, once daily
Drug: Valsartan
Drug: Placebo
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]
    measured by ambulatory blood pressure monitoring (ABPM)

  2. Change in mean DBP during the last 6 hours of the 24 hour dosing interval [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures :
  1. Change in 24-hour mean systolic blood pressure (SBP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]
  2. Change in mean SBP during the last 6 hours of the 24-hour dosing interval [ Time Frame: up to 8 weeks ]
  3. Change in pulse pressure (PP) [ Time Frame: up to 8 weeks ]
  4. Change in 24-hour mean DBP after an active dose of study medication [ Time Frame: up to 8 weeks ]
  5. Change in 24-hour mean SBP after an active dose of study medication [ Time Frame: up to 8 weeks ]
  6. Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose [ Time Frame: up to 8 weeks ]
  7. Change in the mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after an active dose of study medication [ Time Frame: up to 8 weeks ]
  8. Responder rate measured by ABPM after a missed dose of study medication [ Time Frame: Baseline, Day 41, Day 55 ]
    • ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
    • ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
    • ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)

  9. Responder rate measured by ABPM after an active dose of study medication [ Time Frame: up to 8 weeks ]
    • ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
    • ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
    • ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)

  10. Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication [ Time Frame: Baseline, Day 41, Day 55 ]
    • DBP "control" (DBP < 90 mmHg),
    • DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
    • SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
    • BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
    • BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).

  11. Responder rate in- clinic manual trough cuff measurements after an active dose of study medication [ Time Frame: up to 8 weeks ]
    • DBP "control" (DBP < 90 mmHg),
    • DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
    • SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
    • BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
    • BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).

  12. Number of patients with adverse events [ Time Frame: up to 8 weeks ]
  13. Change in 24-hour Pulse Pressure (PP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmHg and ≤ 109 mmHg, measured by manual cuff sphygmomanometer, at Visit 2
  2. 24-hour mean DBP of ≥ 85 mmHg at Visit 3 as measured by ABPM
  3. Age 18 years or older
  4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
  5. Patient's written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who

    1. are not surgically sterile,
    2. are nursing,
    3. are of child-bearing potential and are NOT practising acceptable methods of birth control, or do NOT plan to continue practising an acceptable method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives and Intra Uterine Devices (IUD)
  2. Known or suspected secondary hypertension
  3. Mean sitting SBP ≥180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in period
  4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    1. Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) or Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) > than 2 times the upper limit of normal range,
    2. Serum creatinine > 2.3 mg/dL (or > 203 μmol/l)
  5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
  6. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
  7. Uncorrected volume depletion
  8. Primary aldosteronism
  9. Hereditary fructose intolerance
  10. Biliary obstructive disorders
  11. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
  12. History of drug or alcohol dependency within six months prior to start of run-in period
  13. Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
  14. Any investigational therapy within one month of signing the informed consent form
  15. Congestive heart failure (New York Heart Association (NYHA) functional class Congestive Heart Failure (CHF III-IV))
  16. Unstable angina within the past three months prior to start of run-in period
  17. Stroke within the past six months prior to start of run-in period
  18. Myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
  19. Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past three months prior to start of run-in period
  20. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
  21. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  22. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
  23. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 Ante Meridiem (AM)
  24. Known hypersensitivity to any component of the formulations
  25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
  26. Inability to comply with the protocol

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02242318     History of Changes
Other Study ID Numbers: 502.376
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action