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An antihypertensive intervention trial to lower blood pressure in untreated hypertensive patients based on the gene polymorphisms in the pathway of the drug-metabolism and biological effects

Antihypertensive effects and side effects of Atenolol, Captopril, Nifidipine Sustained Release and Hydrochlorothiazide relative to the gene polymorphisms in untreated hypertensive patients in Rural China

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000108415
Enrollment
4000
Registered
2007-02-07
Start date
2005-03-28
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Hypertension is an important public health problem. The inter-individual clinical response to antihypertensive therapy is highly variable. Genetic variations may influence the clinical response to antihypertensive treatment and side effects. This double-blind, active-controlled randomized trial was aimed to investigate the association between polymorphisms of candidate genes and blood pressure response to antihypertensive drugs in untreated hypertensive patients in countryside Chinese. All study medications were identical in appearance. The code was used to conceal drug name. The drugs were distributed to four groups according to predetermined number of each block.

Interventions

Group 1: Single tablet orally taken twice daily, 12.5 and 25 milligrams of Hydrochlorothiazide. Group 2: Single tablet, twice daily, 12.5 and 25 milligrams of Atenolol. Group 3: Single tablet, twice daily, 20 and 40 milligrams of Nifedipine Sustained Release Group 4: Single tablet, twice daily, 25 and 50 milligrams of Captopril. All interventions were for eight weeks. Patients were first treated with lower dosage; if their blood pressure was still above 140/90 mmHg after two weeks, the dosage w

Group 1: Single tablet orally taken twice daily, 12.5 and 25 milligrams of Hydrochlorothiazide. Group 2: Single tablet, twice daily, 12.5 and 25 milligrams of Atenolol. Group 3: Single tablet, twice daily, 20 and 40 milligrams of Nifedipine Sustained Release Group 4: Single tablet, twice daily, 25 and 50 milligrams of Captopril. All interventions were for eight weeks. Patients were first treated with lower dosage; if their blood pressure was still above 140/90 mmHg after two weeks, the dosage was increased to the second higher dosage.

Sponsors

Cardiovascular Institute, Chinese Academy of Medical Sciences
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Untreated hypertensive patients, including those with newly diagnosed hypertension ( systolic/diastolic blood pressure >=160/95mmHg at two visits), and those with history of hypertension but not receiving antihypertensive treatment for at least 8 weeks (systolic/diastolic blood pressure >=140/90mmHg at two visits).

Exclusion criteria

Secondary hypertension; contraindication to any studied drugs; serum potassium values<3.5mEq/L or >5.5mEq/L at screening stage; requirement for any study drugs for reasons other than hypertension; low likelihood of compliance with protocol (eg, dementia, substance abuse); and a history of any severe, life-threatening disease within the past 3 years.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026