To Evaluate the Efficacy and Safety of Moxonidine tablets in Patients with Uncontrolled Hypertensio
- Conditions
- Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: I11- Hypertensive heart disease
- Registration Number
- CTRI/2020/12/029503
- Lead Sponsor
- Dr Atul Rajkondawar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult male or female patients between 18 to 65 years (both ages inclusive)
2. Patients with uncontrolled hypertension receiving stable dose of three drug combination of Amlodipine 5 mg + Telmisartan 40 mg + Chlorthalidone 12.5 mg in a fixed dose combination for at least 6 weeks prior to randomization and who require treatment with Moxonidine based on investigatorâ??s discretion
3. Patients willing to give their written informed consent to participate in the study
4. Patients willing to comply with all aspects of the protocol
1.Patients with seated systolic blood pressure more than or equal to 180 mmHg and/or diastolic blood pressure more than or equal to 110 mmHg
2.Patients hypersensitive to active or inactive ingredients of investigational products
3.Patients with uncontrolled diabetes mellitus at screening
4.Apparent/pseudo resistant hypertension due to white coat effect, medical inertia, poor therapeutic adherence, or history of secondary causes of hypertension
5.Currently receiving beta-blocker as one of the antihypertensive agents or has received beta-blocker in past 6 months prior to screening
6.Currently receiving or received in 6 months prior to screening alpha adrenoreceptor, imidazole receptor or any other centrally acting drugs as part of antihypertensive drug
7.Patients with predisposition to atrioventricular block, or known history of symptomatic hypotension or orthostatic hypotension, clinically significant electrolyte imbalance
8.Patients with serum creatinine more than 1.8 mg/dL
9.Female patients who are pregnant, lactating, or planning to become pregnant.
10.Female patients not willing to use acceptable method of contraception
11.Patients receiving tricyclic antidepressants, benzodiazepine or have received within the past month prior to screening and systemic steroids, thyroid hormones, oral contraceptives, antipsychotic drugs, nonsteroidal antiinflammatory drugs (NSAIDs), sympathomimetics, immunosuppressants, etc. have been continuously administered for more than 12 weeks prior to visit 1 (screening)
12.History of clinically significant hematologic, hepatic, biliary obstructive disorders, neurologic (including extra pyramidal disorder), psychiatric, renal, cardiovascular (e.g. heart failure, bradycardia [resting heart rate <50 beats per minute], severe bradyarrythmia, sick-sinus syndrome, atrioventricular block, malignant arrhythmia, severe coronary artery disease, unstable angina, vascular heart disease), endocrine, or other diseases that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study
13.Patients scheduled/expected to undergo surgery during the study period
14.Patients who have received any intervention in a clinical trial within 3 months prior to screening
15.Patients with history of alcohol and/or drug/substance abuse & current significant alcohol consumption which as per PI judgment, make the patient ineligible to participate in the study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in sitting SBP and DBP on Day 57 (±4 days) in both treatment groups.Timepoint: Day 57 (±4 days)
- Secondary Outcome Measures
Name Time Method Change from baseline in sitting SBP and DBP on Day 28 (±4 days) in both treatment groups <br/ ><br>Proportion of patients achieving goal BP during the study in both treatment groupsTimepoint: Day 28 (±4 days)