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HypertensionPhase 4NCT02242318

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

A Phase 4 study testing Telmisartan and Valsartan in people with Hypertension, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Telmisartan and Valsartan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
No sites listed yet
Study dates
Sep 2001to Sep 2002
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 24-hour mean DBP of ≥ 85 mmHg at Visit 3 as measured by ABPM
  • Age 18 years or older
  • Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
  • Patient's written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

  • Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
  • are not surgically sterile,
  • are nursing,
  • 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)
  • Known or suspected secondary hypertension
  • Mean sitting SBP ≥180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in period
Show all 31Show fewer
  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
  • 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,
  • Serum creatinine > 2.3 mg/dL (or > 203 μmol/l)
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
  • Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
  • Uncorrected volume depletion
  • Primary aldosteronism
  • Hereditary fructose intolerance
  • Biliary obstructive disorders
  • Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
  • History of drug or alcohol dependency within six months prior to start of run-in period
  • Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
  • Any investigational therapy within one month of signing the informed consent form
  • Congestive heart failure (New York Heart Association (NYHA) functional class Congestive Heart Failure (CHF III-IV))
  • Unstable angina within the past three months prior to start of run-in period
  • Stroke within the past six months prior to start of run-in period
  • Myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
  • Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past three months prior to start of run-in period
  • Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  • 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%
  • Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 Ante Meridiem (AM)
  • Known hypersensitivity to any component of the formulations
  • Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
  • Inability to comply with the protocol

About this study

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

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)

Conditions
Hypertension
Being tested
Telmisartan, Valsartan, Placebo
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelmisartanDrug

  • ValsartanDrug

  • PlaceboDrug

Study groups in NCT02242318
Study groupRoleWhat they receive
TelmisartanExperimentallow dose for two weeks, then up titration to high dose, once daily
Receives: Drug: Telmisartan; Drug: Placebo
ValsartanActive comparatorlow dose for two weeks, then up titration to high dose, once daily
Receives: Drug: Valsartan; Drug: Placebo
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose

    measured by ambulatory blood pressure monitoring (ABPM)

    Measured: Baseline, Day 41, Day 55

  2. Change in mean DBP during the last 6 hours of the 24 hour dosing interval

    Measured: up to 8 weeks

Secondary outcomes (13)

  1. Change in 24-hour mean systolic blood pressure (SBP) after a missed dose

    Measured: Baseline, Day 41, Day 55

  2. Change in mean SBP during the last 6 hours of the 24-hour dosing interval

    Measured: up to 8 weeks

  3. Change in pulse pressure (PP)

    Measured: up to 8 weeks

  4. Change in 24-hour mean DBP after an active dose of study medication

    Measured: up to 8 weeks

  5. Change in 24-hour mean SBP after an active dose of study medication

    Measured: up to 8 weeks

  6. Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose

    Measured: 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

    Measured: up to 8 weeks

  8. Responder rate measured by ABPM after a missed dose of study medication

    • 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)

    Measured: Baseline, Day 41, Day 55

  9. Responder rate measured by ABPM after an active dose of study medication

    • 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)

    Measured: up to 8 weeks

  10. Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication

    • 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).

    Measured: Baseline, Day 41, Day 55

  11. Responder rate in- clinic manual trough cuff measurements after an active dose of study medication

    • 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).

    Measured: up to 8 weeks

  12. Number of patients with adverse events

    Measured: up to 8 weeks

  13. Change in 24-hour Pulse Pressure (PP) after a missed dose

    Measured: Baseline, Day 41, Day 55

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study startSep 2001
  3. Primary completionSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242318
Sponsor's protocol ID
502.376
Status last verified
Sep 2014
First submitted
16 Sep 2014
Last updated
17 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan and Valsartan in people with Hypertension, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose (time frame: Baseline, Day 41, Day 55). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02242318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.

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