A Phase 4 interventional study of Amlodipine and Bisoprolol in Hypertension and Pharmacogenetics, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to male participants aged 35 Years to 59 Years. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment
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Among 187 studies testing amlodipine in Hypertension — 7 open to participants now, 8 under way, 2 of them phase 3. Amlodipine · Hypertension.
Among the 187 studies testing amlodipine in Hypertension, this one is the 77th largest by enrollment of the 186 interventional ones that give a count, is one of 2 that started in 1999, is one of 80 in phase 4, and was the 151st registered.
6,120 studies on the registry are indexed under Hypertension; 913 are open to participants now.
Browse Hypertension studies →7 of the 187 studies testing amlodipine in Hypertension are open now, in 4 countries. Recruiting first, the newest first:
National Medical Research Center for Therapy and Preventive Medicine · Sites in Russia
Ages 50–70
Third Military Medical University · Sites in China
Ages 18–70
Shenzhen Ausa Pharmed Co.,Ltd · Sites in China
Ages 45–74
Shenzhen Ausa Pharmed Co.,Ltd · Sites in China
Ages 45–74
Hyundai Pharm · Sites in Korea, Republic of
Ages 19+
By country, each count listing its studies:
Amlodipine: first FDA approval 1992 (NORVASC), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 563 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 139 take healthy volunteers.
This study: 35 Years to 59 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 9 · Phase 3 71 · Phase 4 80
First in 1999; this study’s year is marked. 2 started in 1999.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 233 is above the median of 100 across 4,579 interventional studies indexed under Hypertension.
Median enrollment 180 across the 186 interventional studies. Of the 156 that completed or were terminated, 53 (34%) have results posted.
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120 of 187 have an industry lead sponsor. The 10 most frequent:
Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Helsinki University Central Hospital has 2 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 187 studies testing amlodipine in Hypertension, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Blood pressure variation and the risk of essential hypertension have an important genetic component. In most cases susceptibility to essential hypertension is likely determined by the action of more than one gene.
The identification of genes causing susceptibility to hypertension is important, since it would give new tools for the diagnosis and enable better etiological classification and specific treatment of the disease.
The innovation of this study is to use the response to antihypertensive therapy as an intermediate phenotype.
In the study, each subject uses one of four antihypertensive drugs, each as a monotherapy in a rotational fashion, for 28 days in a randomized order. The antihypertensive drugs to be tested include a thiazide diuretic, a beta-adrenergic antagonist, an angiotensin-II receptor antagonist and a calcium channel blocker. The drugs that are selected for the study are "typical" representatives of their groups and long-acting, and the dosages are sufficient but well tolerable.
Blood pressure variation and the risk of essential hypertension have an important genetic component. In most cases susceptibility to essential hypertension is likely determined by the action of more than one gene.
The identification of genes causing susceptibility to hypertension is important, since it would give new tools for the diagnosis and enable better etiological classification and specific treatment of the disease. Finland is an ideal place for a study like this because of the genetic homogeneity of the population, the relatively high prevalence of the disease and the established protocols for the treatment and follow-up of hypertension in public health care.
The molecular genetic studies on hypertension performed so far (by 1999) have primarily been association studies, which are based on case-control classification and may produce erroneous results. Particularly, a reliable phenotyping of cases and controls has been difficult. Consequently, more attention should be paid to the phenotyping of patients, and novel intermediate phenotypes characteristic of certain subtypes of hypertension should be used to facilitate the search for hypertension genes. The innovation of this study is to use the response to antihypertensive therapy as an intermediate phenotype.
In the study, each subject uses one of four antihypertensive drugs, each as a monotherapy in a rotational fashion, for 28 days in a randomized order. The antihypertensive drugs to be tested include a thiazide diuretic, a beta-adrenergic antagonist, an angiotensin-II receptor antagonist and a calcium channel blocker. The drugs that are selected for the study are "typical" representatives of their groups and long-acting, and the dosages are sufficient but well tolerable. The study design does not necessitate the use of equipotent doses of the various agents, since the study is not designed to compare the antihypertensive effectiveness of the study drugs or, due to the short treatment periods, their effects on clinical endpoints.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria (before and during the study):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One of the four monotherapy treatment periods.
Drug: Amlodipine
One of the four monotherapy treatment periods.
Drug: Bisoprolol
One of the four monotherapy treatment periods.
Drug: Hydrochlorothiazide
One of the four monotherapy treatment periods.
Drug: Losartan
Placebo treatment period.
Drug: Placebo
Treatment for four weeks. Dose: 5 mg o.d.
Treatment for four weeks. Dose: 5 mg o.d.
Treatment for four weeks. Dose: 25 mg o.d.
Treatment for four weeks. Dose: 50 mg o.d.
Treatment for four weeks. Dose: 1 tablet per day.
Blood pressure
Change in blood pressure
Time frame: 4 weeks
Plan to share: No
Ran from Nov 1999 to primary completion in Apr 2004, 52 months.
Of 126 non-industry phase 4 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 52 months is above that.
Counting every sponsor, half of 161 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amlodipine · Bisoprolol · Hydrochlorothiazide · Losartan
Helsinki University Central Hospital →