Comparison of the Efficacy and Safety of Low Dose Combination Therapy and High Dose Monotherapy for the treatment of Hypertension.
- Conditions
- Health Condition 1: null- Hypertension
- Registration Number
- CTRI/2013/08/003905
- Lead Sponsor
- Self
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
1 Hypertensive patients with uncontrolled blood pressure (Systolic BP >= 140 to 179 mmHg and/or Diastolic BP >= 90 to 109 mmHg) on low dose monotherapy with either Amlodipine (<= 5mg) or Telmisartan (<= 40 mg).
2 Age 18 to 60 years, either gender.
3 Patients who are willing to participate and sign consent document.
4 Patient willing to comply with the protocol requirements.
1 Secondary Hypertension.
2 Clinically evident concomitant disorder such as cardiovascular, renal, hepatic, endocrine, neurological, psychiatric or other complicating diseases or severe co-morbidities.
3 Pregnant or lactating women.
4 Female patients of childbearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study period.
5 Patients with known hypersensitivity to any of the test drug.
6 Patients with alcohol or drug dependence.
7 Patients with stage 3 hypertension (Systolic BP >= 180 mmHg and/or Diastolic BP >= 110 mmHg)
8 Patients who had any major surgery within 4 weeks of screening.
9 Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Blood Pressure Control from BaselineTimepoint: 56 Days of Study Duration
- Secondary Outcome Measures
Name Time Method Improvement in symptoms associated with high blood pressureTimepoint: 56 Days of Study Duration