Losartan for High Blood Pressure

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
San Francisco Veterans' Affairs Medical Center, San Francisco, CAHigh Blood Pressure+1 MoreLosartan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if losartan can improve cardiopulmonary outcomes in people with pre-COPD caused by long-term exposure to secondhand tobacco smoke. The trial is double-blind, meaning neither the participants nor the researchers will know who is taking losartan or the placebo until the trial is over.

Eligible Conditions
  • High Blood Pressure
  • Cardiovascular Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

4 Primary · 15 Secondary · Reporting Duration: At baseline assessment (V1); 4th week of V2 (placebo/losartan) treatment period; and 4th week of V3 (placebo/losartan) treatment period

At baseline assessment (V1); 4th week of V2 (placebo/losartan) treatment period; and 4th week of V3 (placebo/losartan) treatment period
Change in Mean C-Reactive Protein (CRP) Level
Baseline, approximately 1 day
Mean Aortic pulse wave velocity (PWV)
Mean Left Ventricular Ejection Fraction (LVEF)
Mean Left Ventricular Mass
Mean Left Ventricular Volume
Up to 10 weeks
Change in Mean Angiotensin Converting Enzyme (ACE) Level
Change in Mean Change in Borg Score
Change in Mean Endothelin-1 Level
Change in Mean Fibrinogen Level
Change in Mean Maximum Oxygen Pulse
Change in Mean Maximum Workload
Change in Mean Moderate-to-Vigorous Physical Activity (MVPA)
Change in Mean P-selectin Level
Change in Mean Peak Oxygen Consumption (VO2 Peak) Level
Change in Mean Slope of Diastolic Blood Pressure (DBP)
Change in Mean Slope of Heart Rate (HR)
Change in Mean Slope of Systolic Blood Pressure (SBP)
Change in Mean von Willebrand Factor (VWF)
Change in Prevalence of CD14++CD16-

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Statin and/or Angiotensin Receptor Blocker
43%Laboratory values outside normal range
23%Psychiatric Hospitalization
6%Medical Hospitalization
2%Elevated creatine kinase level
1%Muscle pain
1%Hypotension
1%Dehydration
1%Leukemia
1%Placed on Lithium while on Losartan
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02188121) in the Statin and/or Angiotensin Receptor Blocker ARM group. Side effects include: Laboratory values outside normal range with 43%, Psychiatric Hospitalization with 23%, Medical Hospitalization with 6%, Elevated creatine kinase level with 2%, Muscle pain with 1%.

Trial Design

2 Treatment Groups

Placebo then Losartan
1 of 2
Losartan then Placebo
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Losartan · Has Placebo Group · Phase 4

Placebo then LosartanExperimental Group · 2 Interventions: Placebo, Losartan · Intervention Types: Drug, Drug
Losartan then PlaceboExperimental Group · 2 Interventions: Placebo, Losartan · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640
Losartan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline assessment (v1); 4th week of v2 (placebo/losartan) treatment period; and 4th week of v3 (placebo/losartan) treatment period

Who is running the clinical trial?

Flight Attendant Medical Research InstituteOTHER
12 Previous Clinical Trials
2,572 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,226 Total Patients Enrolled
Mehrdad Arjomandi, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
147 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is the recruitment process for this study still open?

"Clinicaltrials.gov reports that this medical investigation is actively seeking participants, with the trial first uploaded on March 30th 2021 and amended as recently as April 29th 2022." - Anonymous Online Contributor

Unverified Answer

What is the total number of participants in this trial?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial, initially listed on March 30th 2021, is actively recruiting participants from a single location and requires 100 patients in total." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration approved Losartan for medical use?

"The existing data detailing Losartan's safety classifies it as a 3, considering that this is Phase 4 of the clinical trial process and therefore has been approved." - Anonymous Online Contributor

Unverified Answer

What is the ultimate aim of this clinical research?

"This clinical trial will be conducted over a 1-day baseline period and aims to measure the Change in Mean Peak Oxygen Consumption (VO2) Level. Secondary outcomes that are being assessed include changes in maximum oxygen pulse, diastolic blood pressure slope, and systolic blood pressue slope." - Anonymous Online Contributor

Unverified Answer

What ailments does Losartan commonly address?

"Losartan may be prescribed to those suffering from hypotension, as well as various other maladies including diabetic nephropathy, left ventricular hypertrophy, and proteinuria." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.