None listed
Conditions
Interventions
GROUP 1 Type of group
1) Introductory Period: Duration of 3-4 weeks. All patients will receive Telmisartan Placebo PO, QD + Ramipril Placebo PO, QD.
2) Active Treatment Period: Duration of 8 weeks. This group will continue with Telmisartan Placebo PO, QD + Ramipril Placebo PO, QD
Group name:GROUP 12 Type of group
1) Introductory Period: Duration of 3-4 weeks. All patients will receive Telmisartan Placebo PO, QD + Ramipril Placebo PO, QD.
2) Active Treatment Period: Duration of 8 weeks. This group will be treated with Telmisartan 80 mg PO, QD + Ramipril 5 mg PO, QD for 2 weeks and then increase the dose to 20 mg for the next 6 weeks to complete the 8 weeks of the active treatment period.
Sponsors
BOEHRINGER INGELHEIM PHARMA,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent in accordance with GCP and local legislation 2. Hypertension defined by an average diastolic blood pressure taken in a sitting position, with cuff, ≥95 mmHg and ≤ 119 mmHg at Visit 3. 3. 18 years of age (or older according to state or provincial local policies). 4. Ability to suspend any current antihypertensive treatment without unacceptable risk to the patient.
Exclusion criteria
Exclusion criteria: 1. Pre-menopausal women who: a) are not surgically sterile; or b) are breastfeeding, or c) are pregnant, or d) have reproductive potential and are NOT using acceptable methods of birth control, or DO NOT plan to continue with an acceptable method throughout the study. 2. Night workers who routinely sleep during the day and whose work at night includes the period between midnight and 4:00 a.m. 3. Known or suspected secondary hypertension. 4. DBP ≥ 120 mmHg and / or SBP ≥ 180 mmHg average taken in the clinic, in a sitting position, with a cuff or during any previous visit to the randomization. 5. Hepatic and / or renal dysfunction defined by the following laboratory parameters: a. SGPT (ALT) or SGOT (AST)> 2 times the upper limit of the normal range, or b. Serum creatinine> 3.0 mg / dL (or> 265 pmol / 1). 6. Bilateral stenosis of the renal artery, stenosis of the renal artery in a single kidney, patients with a kidney transplant or patients with only one kidney 7. Clinically relevant hypokalemia or hyperkalemia. 8. Uncorrected sodium or volume depletion. 9. Primary aldosteronism. 10. Hereditary fructose intolerance. 11. Obstructive biliary disorders or liver failure. 12. Congestive heart failure, functional class of NYHA III or IV. 13. Contraindication for an introductory placebo period. 14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other clinically relevant cardiac arrhythmia. 15. Obstructive hypertrophic cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve. 16. Patients whose diabetes has not been stable and controlled for at least the previous 3 months. 17. Patients who have previously experienced characteristic symptoms of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists 18. History of dependence on drugs or alcohol within the previous six months. 19. Concomitant administration of any medication with known effect on blood pressure. 20. Any experimental pharmacotherapy within a month of signing the informed consent form. 21. Known hypersensitivity to any component of the study drugs. 22. History of non-compliance or inability to comply with prescribed medications or protocol procedures. 23. Any clinical condition that would not allow a safe completion of the protocol and a safe administration of the study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Blood pressure is taken in the clinic, with an inflatable cuff, in a sitting position. Measure:Change from baseline assessment, in diastolic blood pressure (DBP) valley. Timepoints:After 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Blood pressure is taken in the clinic, with an inflatable cuff, in a sitting position. The response to treatment will be defined as: 1) Control of PAD: average PAD <90 mm Hg in the valley. 2) PAD response: average PAD <90 mm Hg in the valley and / or a reduction from baseline evaluation ≥ 10 mm Hg. 3) SBP response: Average SBP <140 mm Hg in the valley and / or a reduction from the baseline assessment ≥ 10 mm Hg. 4) Normal PA: a) Optimal: average SBP <120 mm Hg and mean DBP <80 mm Hg in the valley. b) Normal: mean SBP ≥120 and <130 mmHg and average DBP ≥80 and <85 mmHg in the valley. c) Normal high: average SBP ≥ 130 and <140 mm Hg and average DBP ≥85 and <90 mm Hg in the valley. d) No: average SBP ≥ 140 mm Hg and / or average DBP ≥ 90 mm Hg in the valley. Measure:1) Change from baseline evaluation in systolic blood pressure (SBP) valley. 2) Percentage of patients who respond to treatment based on average blood pressure measurements. Timepoints:After 8 weeks of active treatment. ; Outcome name:AMBULATORY MONITORING OF THE ARTERIAL PRESSURE (MAP): The monitor will be calibrated comparing 5 measurements with those of a mercury sphygmomanometer, and should not differ by more than 5 mm Hg. A sleeve of appropriate size will be selected for the non-dominant arm of the patient. Continuous BP measurements will be performed for the next 24 hours. Measure:1) Changes from the baseline assessment in the PAD and PAS averages. 2) Changes from the baseline assessment in the averages for PAD and PAS. Timepoints:24 hours after the 8 weeks of active treatment. ; Outcome name:Evaluation of adverse events: They will be recorded as non-serious or serious adverse events. Laboratory analysis: blood chemistry and hematology panels. Electrocardiograms: 12-lead ECG. The interpretation will be performed by the Investigator or a medically qualified person. Pulse frequency: It will be eval | — |
Countries
Argentina, Canada, Chile, Mexico, Peru, United States
Outcome results
None listed