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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467384
• Other study ID #: sashah0002
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2022
• Source: Ayub Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion criteria for cases.

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.

Inclusion criteria for controls

1. Normal lipid profile.

2. Normotensive (BP < 140/90mmHg). Exclusion criteria for controls

1) Any major illness.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Amlodipine
5mg/day in two divided doses

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ayub Teaching Hospital	Khyber Medical University Peshawar

References & Publications (12)

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. — View Citation

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. — View Citation

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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2014 May 7;311(17):1809. — View Citation

Johnson LK, Hofsø D, Aasheim ET, Tanbo T, Holven KB, Andersen LF, Røislien J, Hjelmesæth 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. — View Citation

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

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. Erratum in: J Hypertens. 2007 Aug;25(8):1749. — View Citation

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. Epub 2016 Aug 24. — View Citation

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. — View Citation

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. Erratum in: Br J Gen Pract. 2010 Jul;60(576):536. Dua, Jalan Sungai [removed]. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Blood Glucose Concentration	Measured as per protocols provided by the kit manufacturer.	Four Months
Primary	Measurement of Total Plasma Cholesterol Concentration	Measured as per protocols provided by the kit manufacturer.	Four Months
Primary	Measurement of Plasma Triglyceride Concentration	Measured as per protocols provided by the kit manufacturer.	Four Months
Primary	Measurement of Plasma High Density Lipoproteins Concentration	Measured as per protocols provided by the kit manufacturer.	Four Months
Primary	Measurement of Plasma Low Density Lipoproteins Concentration	Measured as per protocols provided by the kit manufacturer.	Four Months