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HypercholesterolemiaPhase 4NCT05467384

Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients

A Phase 4 study testing Amlodipine in people with Hypercholesterolemia and Hypertension, run by Ayub Teaching Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive patients. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
What is being tested?
Amlodipine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
1 Mar 2016to 30 Jun 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1) Newly diagnosed mild to moderate hypertensive. (2) Non-obese individuals. 3) Must not have received antihypertensive treatment previously. 4) Has elevated serum cholesterol levels. Exclusion criteria for cases
  • 1) Any other major illness.
  • Normal lipid profile.
  • Normotensive (BP < 140/90mmHg). Exclusion criteria for controls
  • 1) Any major illness.

Who cannot join

None listed.

About this study

In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive patients.

Read the detailed description

The incidence of hypertension is on the rise in developing countries like Pakistan. Different medications are used to decrease blood pressure with Amlodipine as one of the first-line drugs. It was proposed that due to interaction with calcium and thus luminal cholecystokinin releasing factor; Amlodipine might increase the cholesterol level and thus cause dyslipidemia.

Objective: In this regard, this study was conducted to look into the effects of Amlodipine in newly diagnosed cases of hypertension that had received no medication previously.

Methodology: Experimental study with a healthy control group with the sample size calculated out to be 80, comprising of an equal number of enrolment into case and control groups.

Being tested
Amlodipine
Keywords
Hypercholesterolemia, Hypertension
Medical subject headings
Hypercholesterolemia, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlodipineDrug

    Also called Norvasc

    5mg/day in two divided doses

Study groups in NCT05467384
Study groupRoleWhat they receive
Newly Diagnosed Hypertensive patientsExperimentalThese are the patients that have been clearly diagnosed with diabetes for the first time.
Receives: Drug: Amlodipine
Healthy ControlsNo interventionHealthy Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of Blood Glucose Concentration

    Measured as per protocols provided by the kit manufacturer.

    Measured: Four Months

  2. Measurement of Total Plasma Cholesterol Concentration

    Measured as per protocols provided by the kit manufacturer.

    Measured: Four Months

  3. Measurement of Plasma Triglyceride Concentration

    Measured as per protocols provided by the kit manufacturer.

    Measured: Four Months

  4. Measurement of Plasma High Density Lipoproteins Concentration

    Measured as per protocols provided by the kit manufacturer.

    Measured: Four Months

  5. Measurement of Plasma Low Density Lipoproteins Concentration

    Measured as per protocols provided by the kit manufacturer.

    Measured: Four Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start1 Mar 2016
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Case with healthy control
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467384
Sponsor's protocol ID
sashah0002
Status last verified
Jul 2022
First submitted
16 Jul 2021
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.

    PubMed 24352797

  • Abebe SM, Berhane Y, Worku A, Getachew A. Prevalence and associated factors of hypertension: a crossectional community based study in northwest ethiopia. PLoS One. 2015 Apr 24;10(4):e0125210. doi: 10.1371/journal.pone.0125210. eCollection 2015.

    PubMed 25909382

  • Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available.

    PubMed 17563527

  • Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

    PubMed 12748199

  • Ruilope LM, Burnier M, Muszbek N, Brown RE, Keskinaslan A, Ferber P, Harms G. Public health value of fixed-dose combinations in hypertension. Blood Press Suppl. 2008 Jun;1:5-14.

    PubMed 18705530

  • Saleem F, Hassali AA, Shafie AA. Hypertension in Pakistan: time to take some serious action. Br J Gen Pract. 2010 Jun;60(575):449-50. doi: 10.3399/bjgp10X502182. No abstract available.

    PubMed 20529498

  • Hashmi SK, Afridi MB, Abbas K, Sajwani RA, Saleheen D, Frossard PM, Ishaq M, Ambreen A, Ahmad U. Factors associated with adherence to anti-hypertensive treatment in Pakistan. PLoS One. 2007 Mar 14;2(3):e280. doi: 10.1371/journal.pone.0000280.

    PubMed 17356691

  • Johnson LK, Hofso D, Aasheim ET, Tanbo T, Holven KB, Andersen LF, Roislien J, Hjelmesaeth J. Impact of gender on vitamin D deficiency in morbidly obese patients: a cross-sectional study. Eur J Clin Nutr. 2012 Jan;66(1):83-90. doi: 10.1038/ejcn.2011.140. Epub 2011 Jul 27.

    PubMed 21792214

  • van Ballegooijen AJ, Cepelis A, Visser M, Brouwer IA, van Schoor NM, Beulens JW. Joint Association of Low Vitamin D and Vitamin K Status With Blood Pressure and Hypertension. Hypertension. 2017 Jun;69(6):1165-1172. doi: 10.1161/HYPERTENSIONAHA.116.08869. Epub 2017 Apr 10.

    PubMed 28396533

  • Akoko BM, Fon PN, Ngu RC, Ngu KB. Knowledge of Hypertension and Compliance with Therapy Among Hypertensive Patients in the Bamenda Health District of Cameroon: A Cross-sectional Study. Cardiol Ther. 2017 Jun;6(1):53-67. doi: 10.1007/s40119-016-0079-x. Epub 2016 Dec 29.

    PubMed 28035630

  • Nagai Y, Nakanishi K, Yamanaka N. Direct Renin Inhibitor is Better than Angiotensin II Receptor Blocker for Intrarenal Arterioles. Kidney Blood Press Res. 2016;41(5):561-569. doi: 10.1159/000443459. Epub 2016 Aug 24.

    PubMed 27553090

  • Lauro M, Carbone C, Auditore R, Musumeci T, Santagati N, Aquino R, et al. A new inclusion complex of amlodipine besylate and soluble β-cyclodextrin polymer preparation, characterization and dissolution profile. Journal of Inclusion Phenomena and Macrocyclic Chemistry. 2013;76(1-2)19-28.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amlodipine in people with Hypercholesterolemia and Hypertension, run by Ayub Teaching Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Blood Glucose Concentration (time frame: Four Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467384, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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