None listed
Conditions
Brief summary
To establish the feasibility, patient acceptability, effect on blood pressure and thereby overall potential of a simplified treatment strategy with 'hypertension polypill', which includes four common blood pressure lowering medications each at 1/4 strength dose. This pilot study will be double blind randomised placebo- controlled crossover trial of 50 patients with established hypertension not on any medical therapy. Subjects will be randomised into two arms - intervention (Quadpill) and control (placebo)- for a period of four weeks. They will undergo office blood pressure as well as 24 hour ambulatory BP assessment at baseline and in 4th week in addition to safety monitoring blood tests. Thereafter there will be a 2 week washout phase prior to crossing over to opposite arm of the study. The patients will undergo another baseline blood and 24 hour ambulatory BP assessment. The study will conclude at 10 week with repeat measurements. The outcomes assessed will be change in the mean blood pressure, safety, tolerability and acceptability.
Interventions
The Quadpill will be a single gelatin capsule containing 1/4 standard doses of 4 common blood pressure lowering medications (Irbesartan 37.5 mg, Amlodipine 1.25 mg, Atenolol 12.5 mg and Hydrochlorothiazide 6.25 mg). Participants are randomly allocated to intervention or control therapy during the first cross-over period. Participants allocated to intervention will take one Quadpill orally once daily for 4 weeks, followed by a 2 week wash-out period and then a 4 week period where they will receiv
The Quadpill will be a single gelatin capsule containing 1/4 standard doses of 4 common blood pressure lowering medications (Irbesartan 37.5 mg, Amlodipine 1.25 mg, Atenolol 12.5 mg and Hydrochlorothiazide 6.25 mg). Participants are randomly allocated to intervention or control therapy during the first cross-over period. Participants allocated to intervention will take one Quadpill orally once daily for 4 weeks, followed by a 2 week wash-out period and then a 4 week period where they will receive an identical looking tablet that contains placebo. Participants allocated to control first will receive the above in reverse. There are no additional strategies to improve adherence to the intervention. Adherence will be monitored by drug tablet return and self-report.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Adults aged 18 years and over. 2) Systolic BP>140mmHg or diastolic BP> 90 mmHg on 2 readings on separate days. 3) Treatment Naive. (Not on medical treatment for hypertension). 4) No definite contraindications to quadpill medications, at the doses used in this trial.
Exclusion criteria
1) The responsible clinician feels change in current therapy will place the patient at risk. 2) Severe or Accelerated Hypertension. 3) Pregnancy, Planning Pregnancy in 3 months, Lactating mothers 4) Inability to provide informed consent, 5) Medical illness with anticipated life expectancy < 3 months
Outcome results
None listed