- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242318
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
September 16, 2014 updated by: Boehringer Ingelheim
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
440
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
|
EXPERIMENTAL: Telmisartan
low dose for two weeks, then up titration to high dose, once daily
|
|
ACTIVE_COMPARATOR: Valsartan
low dose for two weeks, then up titration to high dose, once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, Day 41, Day 55
|
Change in mean DBP during the last 6 hours of the 24 hour dosing interval
Time Frame: up to 8 weeks
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
Change in 24-hour mean systolic blood pressure (SBP) after a missed dose
Time Frame: Baseline, Day 41, Day 55
|
Baseline, Day 41, Day 55
|
|
Change in mean SBP during the last 6 hours of the 24-hour dosing interval
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
Change in pulse pressure (PP)
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
Change in 24-hour mean DBP after an active dose of study medication
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
Change in 24-hour mean SBP after an active dose of study medication
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose
Time Frame: up to 8 weeks
|
up to 8 weeks
|
|
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
|
up to 8 weeks
|
|
Responder rate measured by ABPM after a missed dose of study medication
Time Frame: Baseline, Day 41, Day 55
|
|
Baseline, Day 41, Day 55
|
Responder rate measured by ABPM after an active dose of study medication
Time Frame: up to 8 weeks
|
|
up to 8 weeks
|
Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication
Time Frame: Baseline, Day 41, Day 55
|
|
Baseline, Day 41, Day 55
|
Responder rate in- clinic manual trough cuff measurements after an active dose of study medication
Time Frame: up to 8 weeks
|
|
up to 8 weeks
|
Change in 24-hour Pulse Pressure (PP) after a missed dose
Time Frame: Baseline, Day 41, Day 55
|
Baseline, Day 41, Day 55
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (ACTUAL)
September 1, 2002
Study Registration Dates
First Submitted
September 16, 2014
First Submitted That Met QC Criteria
September 16, 2014
First Posted (ESTIMATE)
September 17, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
September 17, 2014
Last Update Submitted That Met QC Criteria
September 16, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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