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Stroke Prevention by Antihypertensive Drugs (SPREAD) Trial

An Antihypertensive Trial to Prevent Stroke with Hydrochlorothiazide combined with Atenolol as required and Nifedipine Sustained Release combined with Captopril as required in patients with hypertension from rural China.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000109404
Acronym
SPREAD
Enrollment
6000
Registered
2007-02-07
Start date
2005-05-28
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. Despite the availability of a variety of effective antihypertensive drugs, there is a large variation in response to these drugs. Most marketed antihypertensive drugs are expensive, and most people in China rural area can not afford them for long-term treatment. This study was aimed to select better cost/effect combinations of antihypertensive drugs for economically less favorite hypertensive patients in developing countries like China. 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

1) Hydrochlorothiazide (single tablet orally taken twice daily, 12.5 or 25 milligrams) based combinations with Atenolol (single tablet, orally, 12.5 or 25 milligrams, twice daily); 2) Nifedipine Sustained Release (single tablet, orally taken, 20 or 40 milligrams, twice daily) based combinations with Captopril (single tablet, orally, 25 or 50 milligrams, twice daily); Check the compliance for antihypertensive drugs once a month. All interventions were for two years. Patients were first treat

1) Hydrochlorothiazide (single tablet orally taken twice daily, 12.5 or 25 milligrams) based combinations with Atenolol (single tablet, orally, 12.5 or 25 milligrams, twice daily); 2) Nifedipine Sustained Release (single tablet, orally taken, 20 or 40 milligrams, twice daily) based combinations with Captopril (single tablet, orally, 25 or 50 milligrams, twice daily); Check the compliance for antihypertensive drugs once a month. All interventions were for two years. 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; if their blood pressure was still above 140/90 mmHg after four weeks, Hydrochlorothiazide based group combined with Atenolol while the Nifedipine Sustained Release based group combined with Captopril.

Sponsors

Cardiovascular Institute, Chinese Academy of Medical Sciences
Lead SponsorOther

Study design

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

Eligibility

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

Inclusion criteria

Hypertensive patients, including untreated hypertensive patients (systolic/diastolic blood pressure >=140/90mmHg at two visits), and treated hypertensive patients (systolic/diastolic blood pressure >=140/90mmHg at two visits).

Exclusion criteria

Secondary hypertension; controindications to any study 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