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Trial record 51 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Fixed-Free HTN Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03578042
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Information provided by (Responsible Party):
Rabih Azar, Hotel Dieu de France Hospital

Brief Summary:
Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: Losartan and amlodipine and hydrochlorothiazide Drug: Standard of care Phase 4

Detailed Description:

Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:

  1. Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
  2. Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.

We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Losartan

Arm Intervention/treatment
Active Comparator: LosanetAMplus
Patients taking the fixed triple combination
Drug: Losartan and amlodipine and hydrochlorothiazide
this is a fixed combination containing the 3 drugs

standard of care
Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician
Drug: Standard of care
any free triple combination therapy for hypertension given as 2 or 3 pills

Primary Outcome Measures :
  1. average 24 hour blood pressure measured by ambulatory recording [ Time Frame: measured after 2 months of therapy ]
    Measured by ambulatory blood pressure recording over 24 hours

Secondary Outcome Measures :
  1. central aortic blood pressure [ Time Frame: measured after 2 months of therapy ]
  2. pulse wave velocity [ Time Frame: measured after 2 months of therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled* Or patients on monotherapy and who have a BP > 160/100 mm Hg

    • BP is defined as UNCONTROLLED if > 135/85 at home or > 140/90 in clinic on at least 2 occasions

Exclusion Criteria:

  • Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction < 3 months old Permanent atrial fibrillation Ejection fraction < 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with > 3 drugs

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 identifier (NCT number): NCT03578042

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Contact: Rabih R Azar, MD, MPH +9611615300 ext 9418

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Hotel Dieu de France Hospital Recruiting
Beirut, Lebanon, Beirut
Contact: Rabih R Azar, MD, MPH    +9611615300 ext 9408   
Sponsors and Collaborators
Hotel Dieu de France Hospital
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Principal Investigator: Rabih R Azar, MD, MPH Hotel Dieu de France Hospital

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Responsible Party: Rabih Azar, MD, MPH, Chief of Cardiology, Hotel Dieu de France Hospital Identifier: NCT03578042     History of Changes
Other Study ID Numbers: Losanet AM Plus trial
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
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
Natriuretic Agents
Sodium Chloride Symporter Inhibitors