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Trial record 3 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT03946514
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine

Brief Summary:
  1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
  2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
  3. Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence.
  4. Objective: To evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy.
  5. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan/hydrochlorothiazide single-pill fixed combination and amlodipine/hydrochlorothiazide.
  6. Study population: Men and Women aged over 18 years (n=300) meeting the inclusion/exclusion criteria.
  7. Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
  8. Follow up: 8 weeks.
  9. Sample size: a total of 300 patients should be enrolled in the combination.
  10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to October 2020. All patients should be followed up before December 2020.

Condition or disease Intervention/treatment Phase
Hypertension Drug: losartan/hydrochlorothiazide Drug: amlodipine/hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: losartan/hydrochlorothiazide group Drug: losartan/hydrochlorothiazide
losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination

Active Comparator: amlodipine/hydrochlorothiazide group Drug: amlodipine/hydrochlorothiazide
amlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet)




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 8 weeks ]
    Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up

  2. Blood pressure control rate [ Time Frame: 8 weeks ]
    The blood pressure controlled rate after 8 weeks of treatment


Secondary Outcome Measures :
  1. Ambulatory blood pressure change [ Time Frame: 8 weeks ]
    The changes of ambulatory blood pressure between two treatment groups after 8 weeks of treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or Women aged between 18 years will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself.

Exclusion Criteria:

  • suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946514


Contacts
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Contact: JiGuang Wang 13764189476 jiguangw@163.com

Locations
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China
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Jiguang Wang, MD, PhD    86-21-64370045 ext 610911    jiguang_wang_jgw@yahoo.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

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Responsible Party: Ji-Guang Wang, Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03946514     History of Changes
Other Study ID Numbers: FOCUS
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine:
Blood pressure
single-pill fixed combination
losartan/hydrochlorothiazide
amlodipine/hydrochlorothiazide
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors