Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental | low dose for two weeks, then up titration to high dose, once daily |
|
| Valsartan | Active Comparator | low dose for two weeks, then up titration to high dose, once daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan | Drug |
| ||
| Valsartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose | 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 | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour mean systolic blood pressure (SBP) after a missed dose | Baseline, Day 41, Day 55 | |
| Change in mean SBP during the last 6 hours of the 24-hour dosing interval | up to 8 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug |
|
| Change in pulse pressure (PP) |
| up to 8 weeks |
| Change in 24-hour mean DBP after an active dose of study medication | up to 8 weeks |
| Change in 24-hour mean SBP after an active dose of study medication | up to 8 weeks |
| Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose | 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 | up to 8 weeks |
| Responder rate measured by ABPM after a missed dose of study medication |
| Baseline, Day 41, Day 55 |
| Responder rate measured by ABPM after an active dose of study medication |
| up to 8 weeks |
| Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication |
| Baseline, Day 41, Day 55 |
| Responder rate in- clinic manual trough cuff measurements after an active dose of study medication |
| up to 8 weeks |
| Number of patients with adverse events | up to 8 weeks |
| Change in 24-hour Pulse Pressure (PP) after a missed dose | Baseline, Day 41, Day 55 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
Not provided