A Phase 4 interventional study of Perindopril Oral Tablet in Diabetes Mellitus, Type 2 and Hypertension, sponsored by Yaounde Central Hospital. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Yaounde Central Hospital · Phase 4, Interventional, and Treatment
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We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.
Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.
Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.
Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Yaounde Central Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mg of perindopril oral tablet once daily in the morning for 56 days
Drug: Perindopril Oral Tablet
10 mg of perindopril oral tablet once daily in the evening for 56 days
Drug: Perindopril Oral Tablet
Perindopril oral tablet morning versus evening
Also known as: Coversyl 10 mg
24-hour blood pressure profile
Overall blood pressure control
Time frame: 56 days
Night time blood pressure dip
Blood pressure drop at night
Time frame: 56 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2016 to primary completion in Jul 2016, 5 months.
Of 320 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's 5 months is below that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Perindopril
Yaounde Central Hospital