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The Precision Hypertension Care Study (PHYSIC)

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ClinicalTrials.gov Identifier: NCT02774460
Recruitment Status : Not yet recruiting
First Posted : May 17, 2016
Last Update Posted : September 13, 2016
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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

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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.
  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. Lithium treatment and 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).
  5. Symptomatic hypotension, defined as weakness or syncope upon rising to an erect position associated with a decrease in systolic blood pressure.
  6. Patients with diabetes requiring insulin or oral glucose-lowering drugs.
  7. Patients with history of serious abnormal drug reaction including angioedema.
  8. Patients with any condition associated with poor compliance including alcoholism or drug dependence.
  9. Patients who will not comply with the study protocol as judged by the Investigator.
  10. Women who are pregnant or lactating or not using appropriate contraception for at least 3 months prior to visit 1.
  11. Patient using concomitant medication that can interfere with study medication, and that according to the Swedish Summary of Product Characteristics (FASS) should not be given.
  12. Clinical laboratory assessment outside normal range at visit 1 as judged by Investigator.
  13. Previous enrolment 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


Contacts
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Contact: Johan Sundstrom, Professor 0046-70 422 52 20 Johan.Sundstrom@medsci.uu.se

Locations
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Sweden
Uppsala University hospital, Internal medicine research, Oscar II Not yet recruiting
Uppsala, Sweden, SE-752 37
Contact: Kerstin Marttala, Study nurse    004618-6113632    kerstin.marttala@akademiska.se   
Principal Investigator: Johan Sundstrom, Professor         
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     History of Changes
Other Study ID Numbers: PHY201501
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
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