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The Precision Hypertension Care Study (PHYSIC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774460
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:

The PHYSIC study aims to investigate the potential for precision medicine in the treatment of high blood pressure.

It is a double-blind, randomized, repeated cross-over trial with six treatment periods: four classes of blood pressure-lowering drugs where treatment with two classes are repeated for each patient. The classes of blood pressure-lowering drugs to be tested are a diuretic, a calcium channel blocker, an ACE-inhibitor and an angiotensin receptor blocker.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Zestril® Drug: Atacand® Drug: Norvasc® Drug: Hydrochlorthiazide® Drug: Treatment X Drug: Treatment Y Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Precision Hypertension Care Study
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zestril® (Lisinopril)
Inhibition of angiotensin converting enzyme (ACE inhibitor). Treatment step up: 1-2 weeks (10 mg tablet) Target dose: 5-7 weeks (20 mg tablet)
Drug: Zestril®
Treatment step up: 1-2 weeks (10 mg tablet) Target dose: 5-7 weeks (20 mg tablet)
Other Name: Lisinopril

Active Comparator: Atacand® (Candesartan)
Angiotensin receptor blocker. Treatment step up: 1-2 weeks (8 mg tablet) Target dose: 5-7 weeks (16 mg tablet)
Drug: Atacand®
Treatment step up: 1-2 weeks (8 mg tablet) Target dose: 5-7 weeks (16 mg tablet)
Other Name: Candesartan

Active Comparator: Norvasc® (Amlodipine)
Calcium channel blocker. Treatment step up: 1-2 weeks (5 mg tablet) Target dose: 5-7 weeks (10 mg tablet)
Drug: Norvasc®
Treatment step up: 1-2 weeks (5 mg tablet) Target dose: 5-7 weeks (10 mg tablet)
Other Name: Amlodipine

Active Comparator: Hydrochlorothiazide® (Hydrochlorothiazide)
Diuretic agent. Treatment step up: 1-2 weeks (12,5 mg tablet) Target dose: 5-7 weeks (25 mg tablet)
Drug: Hydrochlorthiazide®
Treatment step up: 1-2 weeks (12,5 mg tablet) Target dose: 5-7 weeks (25 mg tablet)
Other Name: Hydrochlorthiazide

Active Comparator: Repeated treatment X

Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y.

The repeated arms will be given with the same duration and dosing as the other arms.

Drug: Treatment X
Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y. The repeated arms will be given with the same duration and dosing as the other arms.

Active Comparator: Repeated treatment Y

Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y.

The repeated arms will be given with the same duration and dosing as the other arms.

Drug: Treatment Y
Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y. The repeated arms will be given with the same duration and dosing as the other arms.

Placebo Comparator: Placebo
This is an unblinded placebo run-in which we use to generate baseline values. Each patient will initiate their participation with these 2 weeks of placebo treatment, taking 1 capsule daily.
Drug: Placebo
This is an unblinded placebo run-in which we use to generate baseline values. Each patient will initiate their participation with these 2 weeks of placebo treatment, taking 1 capsule daily.




Primary Outcome Measures :
  1. Between-person variation in blood pressure-lowering effects of blood pressure-lowering drugs, measured as variation in daytime (10 a.m. to 8 p.m.) ambulatory systolic blood pressure. [ Time Frame: This outcome will be analysed based on measurements on the last day of each treatment period (week 7-9). ]

Secondary Outcome Measures :
  1. Between-person variation in side effects of blood pressure-lowering drugs, as measured with a modified section of a validated questionnaire about adverse effects of antihypertensive drugs (PERSYVE section 2.1) [ Time Frame: This outcome will be analysed based on data collected on the next to last day of each treatment period (week 7-9). ]
  2. The difference in patient treatment preferences between the blood pressure lowering drug classes, as measured with a treatment preference rating questionnaire. [ Time Frame: This outcome will be analysed based on data collected on the next to last day of each treatment period (week 7-9). ]
    The questionnaire consists of five questions covering willingness to pay, treatment preference, safety and motivation.

  3. Overall patient treatment preferences measured with a questionnaire on paper. [ Time Frame: This outcome will be measured on the last visit for each patient, i.e. week 56. ]
    The patient is asked to fill out an overall treatment preference rating on paper. The rating is based on a summary of the patients reported symptoms, treatment preference ratings for all treatment periods and a summary of 24 hour blood pressure measurements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged ≥40 years and ≤75 years
  2. Previously diagnosed with hypertension with systolic blood pressure between 140 and 159 mm Hg within five years prior to the start of the trial.
  3. Pharmacologically untreated or using blood pressure-lowering monotherapy at Visit 1. No blood pressure-lowering medication taken during the placebo run-in period.
  4. Office systolic blood pressure between 140 and 179 mm Hg and diastolic blood pressure at or below 109 mm Hg at Visit 2.
  5. Patients must give informed consent to participate in the study.

Exclusion Criteria:

  1. Medical history, clinical signs or laboratory results indicating secondary hypertension, including primary aldosteronism or renal artery stenosis
  2. Evidence of serious hematological, respiratory immunological, renal, hepatic, gastrointestinal, endocrinological, metabolic, neurologic, malignant, psychiatric or other diseases as revealed by medical history, physical examination and/or laboratory assessments.
  3. Active gout
  4. Previous or present arterial occlusive diseases such as myocardial infarction (MI), stroke or acute arterial insufficiency (unstable angina pectoris or transient ischemic attacks, (TIA)) or heart failure (NYHA class III or IV, or left ventricular systolic dysfunction irrespectively of function class).
  5. Moderate or severe aortic or mitral insufficiency.
  6. Renal failure, including hemo-dialysis or kidney transplant/s.
  7. Atrial fibrillation in need of rate control.
  8. Symptomatic hypotension, defined as weakness or syncope upon rising to an erect position associated with a decrease in systolic blood pressure.
  9. Diabetes requiring insulin or oral glucose-lowering drugs.
  10. Any history of serious abnormal drug reaction to active or inactive compounds in the study drugs, including angioedema.
  11. Any condition associated with poor compliance including alcoholism or drug dependence.
  12. Patients who will not comply with the study protocol as judged by the Investigator.
  13. Women who are pregnant or lactating or not using appropriate contraception for at least 3 months prior to visit 1. Acceptable contraceptive methods are: combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomised partner.
  14. Continuous use of concomitant medication that can interfere with study medication, i.e. digitalis glucosides, sotalol, cholestyramine, colestipol, NSAID, lithium, carbamazepine, CYP3A4-inhibitors, CYP3A4-inducers, dantrolene, diuretics, aliskiren, gold, sympathomimetics, tricyclic antidepressants, antipsychotics, anaesthetics and potassium supplements.
  15. Clinical laboratory assessment outside normal range at visit 1 and judged clinically significant by the Investigator.
  16. Previous randomization in present study

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): NCT02774460


Locations
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Sweden
Uppsala University hospital, Internal medicine research, Oscar II
Uppsala, Sweden, SE-752 37
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Johan Sundstrom, Professor Uppsala University, Department of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02774460    
Other Study ID Numbers: PHY201501
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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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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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Candesartan
Candesartan cilexetil
Lisinopril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents