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

NCT05467384 | Completed Phase 4

• 1 other identifier: sashah0002
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypercholesterolemia; Hypertension; Cholesterol Deposition

Keywords

Hypercholesterolemia; Hypertension

Outcome Measures

Primary Outcomes (5)

• Measurement of Blood Glucose Concentration

  Measured as per protocols provided by the kit manufacturer.

  Four Months

• Measurement of Total Plasma Cholesterol Concentration

  Measured as per protocols provided by the kit manufacturer.

  Four Months

• Measurement of Plasma Triglyceride Concentration

  Measured as per protocols provided by the kit manufacturer.

  Four Months

• Measurement of Plasma High Density Lipoproteins Concentration

  Measured as per protocols provided by the kit manufacturer.

  Four Months

• Measurement of Plasma Low Density Lipoproteins Concentration

  Measured as per protocols provided by the kit manufacturer.

  Four Months

Study Arms (2)

Newly Diagnosed Hypertensive patients

EXPERIMENTAL

These are the patients that have been clearly diagnosed with diabetes for the first time.

Drug: Amlodipine

Healthy Controls

NO INTERVENTION

Healthy Control Group

Interventions

Amlodipine DRUG

5mg/day in two divided doses

Also known as: Norvasc

Newly Diagnosed Hypertensive patients

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \) Any other major illness.
• Normal lipid profile.
• \) Any major illness.

Sponsors & Collaborators

• Ayub Teaching Hospital: lead
• Khyber Medical University Peshawar: collaborator

Related Publications (12)

• 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.

  PMID: 24352797 BACKGROUND

• 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.

  PMID: 25909382 BACKGROUND

• 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.

  PMID: 17563527 BACKGROUND

• 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.

  PMID: 12748199 BACKGROUND

• 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.

  PMID: 18705530 BACKGROUND

• 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.

  PMID: 20529498 BACKGROUND

• 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.

  PMID: 17356691 BACKGROUND

• 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.

  PMID: 21792214 BACKGROUND

• 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.

  PMID: 28396533 BACKGROUND

• 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.

  PMID: 28035630 BACKGROUND

• 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.

  PMID: 27553090 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia; Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shahid A Shah, BDS, MPhil

  Faculté d'Odontologie, Université de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Case with healthy control

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 20, 2022
• Study Start: March 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share