Posts Tagged ‘VIAGRA TRIALS’
VIAGRA CLINICAL TRIALS
A great number of clinical trials of Viagra were held to assess the ability of the drug to treat ED and its effectiveness. More than 3700 participants from different countries (aged 19– over 85 years) received Viagra during pre-marketing clinical trials. Over 550 participants were involved in studies for longer than one year.
In several placebo-controlled clinical studies, rate of side effects for Viagra was not significantly different from placebo .The side effects were mostly mild to moderate in nature.
In trials of all designs (including dose, age, health conditions) side effects in participants taking Viagra were generally similar.
In fixed-dose studies, the incidence of some side effects was related to increased dose.
The nature of the side effects in flexible-dose studies, which consider the recommended dosage administration, was similar to that for fixed-dose studies.
When the drug was taken as recommended in clinical trials, the following side effects were commonly reported:
- Headache;
- Flushing;
- Nasal congestion.
Such side effects as abnormal vision, rash, abdominal pain, allergic reaction, chest pain or respiratory tract infection occurred less than 2% of rate. Other side effects were so meaningless in rates that are not worth mentioning.
In fixed-dose studies abnormal vision (11%) was more common at 100 mg than at lower doses.