PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Study Overview
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Brief Summary
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Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.

Official Title
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A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation. 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. Age 18 years or older (or 19 years if dictated by local State/Province policies). Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion). 24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM). Exclusion criteria: Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who: were not surgically sterile; or were nursing, or were of childbearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included IUD, oral, implantable or injectable contraceptives. No exceptions were made. Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m. Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period. Known or suspected secondary hypertension (e.g., phaeochromocytoma). Hepatic and/or renal dysfunction as defined by the following laboratory parameters: Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) >2 times the upper limit of normal range, or Serum creatinine >2.3 mg/dL (or >203 μmol/l). Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia. Uncorrected volume depletion. Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telmisartan|nan|
|Drug: Ramipril|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg) |  | Up to week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytime and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff |  | Up to week 14 |