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OPEN LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF HYZAARTM (LOSARTAN 50 MG / HCTZ 12.5 MG) IN PATIENTS WITH ESSENTIAL HYPERTENSION INADEQUATELY CONTROLLED WITH VALSARTAN MONOTHERAPY OF 80 MG AND TO WHICH THE THERAPY WAS CHANGED

OPEN LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF HYZAARTM (LOSARTAN 50 MG / HCTZ 12.5 MG) IN PATIENTS WITH ESSENTIAL HYPERTENSION INADEQUATELY CONTROLLED WITH VALSARTAN MONOTHERAPY OF 80 MG AND TO WHICH THE THERAPY WAS CHANGED

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-017-05
Enrollment
110
Registered
2005-05-18
Start date
2005-05-30
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
Patients will take Valsartan 80 mg orally, once a day, at the same time every day (between 6 a.m. and 10 a.m.), except for the days when a clinical visit is scheduled. This will be done for 4 weeks. Those patients after 4 weeks have not achieved adequate control of their blood pressure, will stop Valsartan and begin with HYZAAR (Losartan 50mg / HCTZ 12.5 mg) orally, once a day, at the same time every day (between 6 a.m. and 10 a.m.) except for the days when a clinical visit is scheduled. Thi

Sponsors

MERCK & CO.INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Between 18 and 75 years of age. b. Sex: Both male and female patients are acceptable. c. Hospitalization status: Outpatient. d. The patient suffers from essential hypertension. e. Patients must have grandparents by their mother or father / biological parents of patients born in Asia. f. Blood pressure • At visit 1 with a SiDBP> 85 to <95 mmHg. • In visit 2 that show a SiDBP between 95 and 115 mmHg • At Visit 3 only patients who are not controlled will be switched to HYZAAR ™. g. The patient is legally capable and can understand the nature and implications of the clinical study. h. The patient wants to participate in this study.

Exclusion criteria

Exclusion criteria: a) The patient is pregnant or is breastfeeding. b) The patient has known or suspected secondary hypertension. c) The patient has a history of malignant hypertension. d) The patient has a systolic blood pressure while sitting (SiSBP)> 190 mmHg. e) The patient has a history of stroke f) Patients with a history of myocardial infarction within the last 6 months. g) Patient with active history of angina that has not stabilized with medical therapy. h) Patients who have undergone percutaneous coronary intervention or aortocoronary bypass surgery within the previous 6 months. i) Patients with atrioventricular block (second or third degree). j) Patients with complete blockage of the left fascicular branch. k) Patients with atrial fibrillation.

Design outcomes

Primary

MeasureTime frame
Outcome name:Clinical measurement of SiDBP Measure:Efficacy of HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg): Average change in diastolic pressure while the patient is sit (SiDBP) Timepoints:At the 4th week of treatment with HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg)

Secondary

MeasureTime frame
Outcome name:Clinical measurement of SiSBP Measure:Efficacy of HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg): Change averaged with respect to the baseline sistolic pressure while the patient is sitting (SiSBP) Timepoints:At the 4th week of treatment with HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg) ; Outcome name:Clinical measurement of SiDBP Measure:Efficacy of HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg): Proportion of patients reaching the goal (minimum mean diastolic blood pressure with the participant sitting <90 mmHg) Timepoints:At the 4th week of treatment with HYZAAR ™ (Losartan 50 mg / HCTZ 12.5 mg) ; Outcome name:Clinical evaluation Measure:Safety of Valsartan of 80 mg and HYZAAR ™ (Losartan 50mg / HCTZ 12.5mg): Incidence of adverse events (AD) and adverse reactions (AD related to the drug) in each treatment period. Timepoints:At the time of presentation

Countries

Peru

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)