Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

January 31, 2016

Conditions
Hypertension
Interventions
DRUG

ASA evening

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

DRUG

Acetylsalicylic morning

Patients will be assigned in a blind and randomized way to one of two parallel groups: group I with the control treatment during the first two months, namely, administration of aspirin 100 mg, in the morning and placebo in the evening and group II initially receiving the intervention, of administration of aspirin 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups, i.e., patients randomly allocated to group I, so having taken aspirin in the morning and placebo in the evening, will now receive the intervention treatment, namely, administration of ASA in the evening and placebo in the morning for another two months and vice verse.

DRUG

Placebos morning

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

DRUG

Placebo evening

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

Trial Locations (3)

48014

Primary Care Research Unit of Bizkaia, Bilbao

Unknown

Primary care of IDIAP Jordi Gol, Barcelona

Primary Care Research Unit of Bizkaia, Gipuzkoa Oeste

All Listed Sponsors
collaborator

Preventive Services and Health Promotion Research Network

OTHER

collaborator

Spanish Clinical Research Network - SCReN

NETWORK

collaborator

Public Health Service of Cataluña

OTHER

lead

Basque Health Service

OTHER_GOV

NCT01741922 - Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients | Biotech Hunter | Biotech Hunter