A Randomized, Double-Blind Safety and Efficacy Study of Losartan Plus Hydrochlorothiazide Versus Losartan as First-Line Therapy After 6 Weeks in Patients With Severe Hypertensio

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-055-00
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Severe hypertension, and age exceeds the legal age to give consent.
•The patient does not take more than 3 antihypertensive medications before entering the study
•The patient meets the following blood pressure criteria:
• Patients treated: PADSe minimum mean> 95 mm Hg, PASSe minimum mean <220 mm Hg in the selection; PAD Minimum mean> 110 mmHg PASSe minimum mean <220 mm Hg after the washout period and randomization.
• Patients not treated: PADSe mean> 110 mm Hg; PASSe mean <220 mm Hg to the selection and to the randomization.

Exclusion Criteria

1. History of secondary hypertension
2. History of malignant hypertension, or any evidence of active or impending malignant hypertension, including headache, papilloedema, chest pain.
3. History of stroke, transient ischemic attacks, or audible carotid murmurs.
4. Documented history of myocardial infarction or angina pectoris.
5. History of clinically significant atrioventricular conduction disorders (AV) and does not have a permanent pacemaker.
6. History of unexplained syncope within the previous 2 years, or a known syncopal disorder.
7. Antecedents of atrial fibrillation.
8. History of congestive heart failure or known left ventricular ejection fraction <40%.
9. Presence of an obstructive valvular pathology or hemodynamically significant cardiomyopathy.
10. Reaction of known prior sensitivity to losartan or HCTZ or to any other drug derived from sulfonamides.
11. The patient takes other drugs with hemodynamic effects.
12. The patient takes psychotropic medication with possible hemodynamic effects.
13. The patient takes lithium.
14. Is a regular user of DAINEs (daily) or aspirin at high doses.
15. The patient is a concomitant user of ACTH (corticotropin) or oral steroids.
16. Patients undergoing hormone replacement therapy (thyroid, testosterone, estrogen) whose regimen was not stable in the last 3 or more months.
17. Patient shows evidence of significant liver dysfunction as indicated by clinical history or laboratory evaluation.
18. Serum creatinine level> 1.5 mg / dl, and creatinine clearance <60 cm3 / min
19. Proteinuria> 2+.
20. AST level (SGOT) and / or ALT (SGPT) greater than twice the normal upper level.
21. Clinically significant laboratory value outside the established normal range, including without limitation any of the following parameters: hematocrit, hemoglobin or platelet count.
22. White blood cell count <3,000 / mm3.
23. Serum potassium <3.5 or> 5.5 mEq / L.
24. The patient presents hematuria (<20 / hpc) of unknown etiology.
25. The patient is HTV or hepatitis B positive, although no screening is required.
26. History of clinically important malabsorption, gastrointestinal resection or liver cirrhosis.
27. The patient is pregnant or breast-feeding. (NOTE: Women of childbearing age who are not surgically sterilized and use an effective method of contraception or their partner, will only be able to enter the study if they are previously subjected to an exclusionary pregnancy test.
28. Fasting serum glucose levels> 240 mg / dl at the baseline.
29. The patient has severe concurrent disease that could exclude their participation or survival.
30. The patient has a hemorrhagic or platelet disorder.
31. The patient currently abuses or has a well-documented history (within the past 2 years) of having abused alcohol or drugs.
32. Mental or legal incapacity.
33. Participation in another trial with a drug under investigation within 28 days of beginning the baseline period.
34. The patient has a single functioning kidney.
35. The circumference of the patient´s arm is> 41 cm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The measures of effectiveness are constituted by the average of 3 readings of the PASSe and PADSe minimum (by mercury sphygmomanometer) at each visit.<br>The primary response variable that will govern the primary hypothesis is the proportion of patients achieving target blood pressure (average PADSe average <90 mm Hg) at 4 weeks<br>Measure:Efficacy<br>Timepoints:4 weeks<br>;<br>Outcome name:Adverse events of particular interest include hypotension, dizziness, syncope, and worsening of renal function (increase in serum creatinine> 0.5 mg / dl from the baseline).<br><br>In the baseline and in Week 6 of the double blind phase, or at the time of discontinuation, will be made<br>a physical examination, a routine laboratory evaluation, and an electrocardiogram.<br>Measure:Safety<br>Timepoints:From the baseline to week 6<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Average change in the PADSe in all visits.<br>Measure:Efficacy<br>Timepoints:Week 4 and week 6<br>;<br>Outcome name:proportion of patients achieving target blood pressure (average PADSe average <90 mm Hg) at 6 weeks<br>Measure:Efficacy<br>Timepoints:Week 6<br>